Clinical Data Management Resume Samples

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RH
R Huels
Roxane
Huels
5161 Borer Plains
San Francisco
CA
+1 (555) 713 4478
5161 Borer Plains
San Francisco
CA
Phone
p +1 (555) 713 4478
Experience Experience
07/2014 present
Phoenix, AZ
Associate Director, Clinical Data Management
Phoenix, AZ
Associate Director, Clinical Data Management
07/2014 present
Phoenix, AZ
Associate Director, Clinical Data Management
07/2014 present
  • Assists in the training of other Clinical Data Managers or CDM associates through mentoring or developing/conducting training
  • Work closely with Statistics & Programming to ensure high quality data output including data cleaning/validation, SAS listings review, TLF dry runs, etc
  • Contributes to back-end project budget/resource planning, re-forecasting, program milestones, along with CPMs and Clinical Operations management
  • Project team development, resource planning, and cost estimating
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
  • Communications planning, information distribution, performance reporting, and project closure
  • Ensures projects are conducted in compliance with operating procedures and good clinical practices
06/2010 03/2014
Philadelphia, PA
Associate Director Clinical Data Management
Philadelphia, PA
Associate Director Clinical Data Management
06/2010 03/2014
Philadelphia, PA
Associate Director Clinical Data Management
06/2010 03/2014
  • Represent Clinical Data Management at cross-functional forums, meetings and provide timely feedback to partners
  • Lead and support clinical & non-clinical special projects
  • Provides all necessary support to address any issues requiring management input
  • Represents the group in any forums including leadership team meeting to address issues. Ensure process improvements suggestions are evaluated and support team to bring suggestion to management for consideration
  • Provides management oversight for all the activities for Clinical Data Management during study startup
  • Authorizes the GoLive based on a review of completion of all activities for pivotal trials
  • Provides management oversight for all the activities for Clinical Data Management during data finalization
02/2005 02/2010
San Francisco, CA
Director, Clinical Data Management
San Francisco, CA
Director, Clinical Data Management
02/2005 02/2010
San Francisco, CA
Director, Clinical Data Management
02/2005 02/2010
  • Responsible for hiring, training, development and management of staff; ensures effective resource allocation
  • Leads Data Management personnel through audit situations, including closing out audit findings
  • Create, review, and update CDM processes and Standard Operating Procedures
  • Collaborate with Biostatistics and Programming to help build the Biometrics function at Avanir
  • Leads and oversees Clinical Data Management function and EDC programming (through external vendors)
  • Develops departmental policy, standard operating procedures, and work instructions
  • Willing to maintain regular office hours in either our Secaucus or Somerset, NJ offices
Education Education
Bachelor’s Degree in Collaboration With
Bachelor’s Degree in Collaboration With
Florida Atlantic University
Bachelor’s Degree in Collaboration With
Skills Skills
  • Strong leadership skills and ability to work within cross-functional teams
  • Proven ability to manage multiple projects, set priorities and meet deadlines
  • Excellent interpersonal, organizational, and multi-tasking skills
  • Ability to work well on a team and independently
  • Excellent MSOffice skills including Word, Excel, PowerPoint, Outlook
  • Excellent written and verbal English communications skills, including presentation skills
  • Demonstrated strong technical and problem solving skills
  • In-house position based in Waltham, MA
  • Demonstrated team management skills
  • Travel domestic and international – up to 15%
Create a Resume
1

Senior Director, Clinical Data Management Resume Examples & Samples

  • Lead the design and implementation of an Enterprise Data Management capability, including
  • Bachelor’s degree or equivalent required, preferably in the Life Sciences, e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy. Advanced degree is preferred
  • Minimum of 12 years of experience in the pharmaceutical industry, at a CRO or hospital, including extensive clinical research experience
  • Experience in Clinical Data Management is preferred
  • Must have the ability to maintain and improve consistent and sound business processes in a dynamic, cross-cultural environment
  • Must be able to work in a fast paced environment in a global team utilizing multiple communication styles and venues to manage staff and/or business partners in different locations and time zones
  • A proven track record of people and project management
  • Ability to manage complexity and multiple priorities in a matrix environment under pressure
  • Proficient in English language
  • Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint)
  • The position may require up to 25% travel, including both domestic and international
2

Director, Clinical Data Management Resume Examples & Samples

  • Line management responsibilities for staff members. Approves courses of action on interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods. Drives recruitment of operational staff
  • Manages resource management and maintaining utilization/realization at acceptable levels. Ensures that all projects maintain the correct level of gross profit, that budgets are maintained, and changes in scope applied as necessary. Additionally, implements a project review process to ensure that resource, deliverables, scope, quality, and budget are maintained appropriately
  • Manages the achievement of departmental sales, revenue, utilization and gross profit targets
  • Serves as primary interface between company and sponsors, vendors and other departments in the area of data management
  • Serves as an authority in the design and implementation of data management strategies
  • Oversees the planning, execution, and maintenance of major projects, if required
  • Ensures that all aspects of the Company’s data management processes, procedures, and technology are consistent with current industry practices and meet all pertinent regulatory requirements, both domestic and international
  • Develops Standard Operating Procedures (SOPs), data management tools, training, department budgets, and staffing requirements
  • Regularly reviews all relevant projects for financial control and operational productivity
  • Consults with Business Development activities as required. Reviews and approves the Data Management portion of any proposal and budget which dictates the work will be undertaken in the assigned office
  • Leads Data Management personnel through audit situations, including closing out audit findings
  • Maintains current professional knowledge in fields of information management, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate clients
  • Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business. May represent the Company at professional meetings or seminars
3

Director, Clinical Data Management Resume Examples & Samples

  • Selects, develops, and retains high quality employees (particularly managers) setting and achieving objectives that support the overall THV Clinical Affairs goals
  • Evaluates the CDM resources and solves resourcing issues
  • Sponsors and leads process improvement projects within Clinical Data management
  • Works closely with Senior Director, Biometrics and collaborates with other THV Clinical Affairs leadership members to ensure that the CDM SOPs, Work Instructions, and policies are complete and up to date
  • Creates, develops, maintains and enforce CDM policies to ensure the data collection and data cleaning are efficient and meet the needs of THV registration filings
  • Ensures that internal and external resources are trained and equipped to achieve high quality results. This includes training of internal resources and selection and management of vendors
  • Liaises with other Stakeholders within THV Clinical Affairs to assess and continuously improve processes within the department, particularly as related to acquisition of clinical data and delivery of tools that provide information about clinical data status and study conduct metrics
  • Ensures that data management methods used are consistent with industry best practices and regulatory trends and requirements
  • Works with Senior Director, Biometrics to manage the budget for THV Clinical Data Management according to expected standards
  • Bachelor's Degree or equivalent: Computer science, life sciences or related fields (preferred)
  • Focused on Clinical Programming and Data Management
  • Has demonstrated expertise with clinical data management, clinical database design, EDC programming, and application validation
  • Has strong managerial experiences and human skills to lead a team of CDM professionals
  • Has excellent knowledge of global regulatory requirements related to computerized systems used in clinical investigations, data handling, and patient privacy
  • Maintains a high level of knowledge regarding current industry and regulatory trends and requirements and ensures THV Clinical Data Management systems and processes are consistent with these
4

Clinical Data Management Associate Temp Resume Examples & Samples

  • Associate’s degree in a scientific or health-related field is required
  • Minimum of 1-3 years of experience in clinical data management
  • Broad knowledge of data management processes, including EDC experience
  • Understanding of GCPs, FDA regulations and ICH guidelines is required
  • Ability to manage multiple projects and timelines simultaneously
  • Excellent organizational skills and attention to detail are required
5

Global Study Operations Clinical Data Management Manager Resume Examples & Samples

  • Proven project management/lead and planning experience
  • Bachelor’s degree or equivalent in life science, computer science, business administration
  • Experience in RAVE EDC will be highly regarded
  • Experience in working in a global outsourced environment
6

Director, Clinical Data Management Resume Examples & Samples

  • Serve as Head of Data Management (DM) and oversee all DM activities across multiple clinical development programs. Continue to build and expand the DM department
  • Collaborate with Biostatistics and Programming to help build the Biometrics function at Avanir
  • Recruit and train high performing DM staff. Foster career growth within the department and expand the technical expertise of DM staff
  • Coordinate and drive all DM activities to support corporate goals and objectives and deliver timely, high-quality results
  • Develop clinical data standards in strong adherence to CDASH and SDTM guidance
  • Manage clinical data transfers and data outputs across multiple compounds and projects
  • Manage the budget for the DM department and data-related contracts
  • Collaborate with cross-functional individuals from Clinical Operations, Clinical Development, Medical Affairs, Safety/PVG, Regulatory, Project Management, and Clinical Supplies in support of project deliverables and regulatory needs
  • Develop DM SOPs, Work Instructions and/or Guidelines
  • Create thorough data quality checks and data review strategies to ensure the integrity of the clinical data
  • Perform thorough reviews of critical CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans
  • Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells
  • Participate in reviews of blinded TFL output prior to final database locks
  • Establish reports to assist with data cleaning, query metrics, and identification of data trends
  • 15+ years clinical data management experience in the pharmaceutical/CRO industry
  • 15+ years of hands-on Electronic Data Capture (EDC) experience
  • Strong leadership skills within a variety of professional applications that include, but are not limited to: department leadership, project team leadership, and the ability to coordinate activities strategically in support of corporate goals and objectives
  • Exceptional planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
  • Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
  • Proficient in the use of the following software programs: MS Word, MS Project, MS Excel, Adobe publishing
  • Experience with SAS or SQL programming techniques with clinical data management application a plus
  • Experience with writing SOPs, Work Instructions, Data Management Plans and Guidelines
  • Ability to juggle multiple tasks and priorities
  • Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with outside vendors, consultants, and team members
  • Ability to thrive in a fast-paced environment with a sense of urgency and commitment to meet deadlines
7

Associate Director, Clinical Data Management Resume Examples & Samples

  • Prepare data management plans
  • Create, review and update data management SOPs, processes and flow charts
  • Review and quality control study report tables, graphs, and SAS data listings
  • Assist in the design of databases and perform validation of edit and range checks for the databases
  • Assist in the review of the sample case report forms and annotated case report forms
  • Review and quality control checks of study data
  • Supervise entry, and assignment of AE MedDRA and WHODrug codes into database in association with drug safety personnel
  • Assist in the preparation of statistical contributions to study reports and integrated summaries for pharmacokinetic, pharmacodynamic, efficacy and safety analyses
  • Assist BD activities related to DM
8

Clinical Data Management Associate Resume Examples & Samples

  • Works collaboratively with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and other Clinical, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical laboratory data acquisition, quality checking and reporting
  • May lead in the design and implementation of clinical data management processes with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery
  • Leads the design of contracts and data transfer agreements with laboratories for sound and through data collection through the regulatory approval process
  • Reviews study protocols and assists in the planning and implementation of the data management portions of clinical research projects
  • Interacts with lap staff, site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in timely manner
  • Utilizes reports to track study progress and ensure timeliness and quality expectations are met
  • Excellent verbal and written communication skills and interpersonal skills are required
  • The ability to problem solve and have people/project leadership skills
  • General knowledge of FDA regulations and clinical data management systems is also required
  • 1 years of experience and a MS degree or PhD
9

Clinical Data Management Associate Resume Examples & Samples

  • Works collaboratively with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and other Clinical, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
  • Demonstrates a general understanding of each assigned protocol, critical tasks and milestones
  • Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery
  • Assists in the preparation of CRF/eCRF for data collection through the regulatory approval process
  • Assists in implementing routine clinical research projects
  • Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries
  • Knowledge of FDA regulations, support of needs for NDA and other regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems
  • Demonstrates understanding of project timelines and metrics to ensure databases are delivered to timelines
10

Clinical Data Management Team Lead Resume Examples & Samples

  • Manage the DM team according to the Icon way including developing the employees and the team to meet Icon business needs
  • To ensure excellent quality management system within team
  • To ensure excellent organizational effectiveness within team
  • To ensure people development and people engagement within team
  • Follow up on deliverables ensuring timely, high quality and cost-effective outcome and communicate progress to the manager
  • Ensure that all employees in the team are provided the needed support and possesses the necessary competencies
  • Support the team in their communication with stakeholders (e.g. trial management, safety, vendors and management)
11

Associate Director, Clinical Data Management Resume Examples & Samples

  • Select vendors and technology to meet the needs of Kite’s clinical development programs
  • Provide CDM expertise to database set up, CRF design, and data cleaning to efficiently ensure high quality data
  • Manage vendors, and ensure appropriate resources are available to meet the demands of the clinical development programs and regulatory filings
  • Manage CDM deliverables in coordination with internal and external cross functional teams
  • Oversee the development of CDM standards and infrastructure to support global projects
  • Actively participate in the development and review of documents such as CRFs, data management plans, dataset transfer standards, WHODrug and MedDRA coding standards, manual review plans, line listing review plans, and data validation plans
  • Proactively make recommendations regarding the development and use of appropriate tools to further support and strengthen the collection and review of data
  • Ability to collaborate with Statistical Programming, Biostatistics, Drug Safety, CROs and technology providers
  • Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks
12

Associate Director, Clinical Data Management Resume Examples & Samples

  • Partners with functional area representatives to ensure appropriate use of database standards and project-level consistency on database, data collection, review, and retrieval specifications
  • Project plan development, execution, and change control
  • Project team development, resource planning, and cost estimating
  • Risk management
  • Communications planning, information distribution, performance reporting, and project closure
  • Provides direction for integrating external teams into the data management processes and ensures that data from disparate sources and database structures align with the clinical data management strategy. Participates in the development of, and ensures adherence to, MSD clinical and regulatory data management standards
  • Mentors, guides, and provides project leadership for junior staff as assigned
  • Keeps abreast of project and clinical data management disciplines through interaction with experts both within and outside of the company
  • May lead continuous improvement special projects, or perform any other data management tasks deemed appropriate by management
  • At least 6 years’ experience in Clinical Data Management
  • Full life-cycle experience in clinical data management (data collection system development through database lock and close-out
  • At least 3 years’ experience working with project management tools and processes
  • At least 2 years' experience/exposure working in the Oncology Therapeutic area
13

Director, Clinical Data Management Resume Examples & Samples

  • Resolve resource and scheduling issues
  • Work closely with cross-function partners in Clinical and Regulatory Affairs
  • Create, develop, maintain and enforce CDM policies, procedures and work instructions to assure the efficient and effective collection of clean, reliable clinical data
  • Bachelor’s degree or higher: computer science, life sciences or a related field
  • Focused on programming and data management in a clinical or related health-care setting
  • Demonstrated expertise in clinical data management, clinical database design, EDC applications, application validation and user support
  • Managerial experience and people skills to lead a diverse team of CDM professionals
14

Senior Analyst Clinical Data Management Resume Examples & Samples

  • Define and specify clinically complex data collection requirements (such as eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating testing of data collection instruments (e.g. test scripts and checklists) to ensure appropriate data are collected
  • Other incidental duties
  • At least 3 years monitoring or management of clinical studies in European Union (medical device trials preferred, also pharmaceutical trials)
  • Minimum five years experience in clinical research (including a minimum of three years experience in Clinical Data Management (CDM) and/or clinical data entry)
  • Fluent English (written & spoken), additional European language desired
  • Experience with electronic data capture, preferred
  • Excellent written and verbal communication skills, analytical skills, strong organizational skills, self-motivated, flexibility and adaptability
15

Director, Clinical Data Management Resume Examples & Samples

  • Supervisory and leadership responsibilities for all data management and back-end activities supporting Alkermes clinical programs from DM strategy, database start-up through database lock and CSR/submission
  • Manages relationships and establishes partnerships with CROs, vendors, and other external partners including strategic partnerships and preferred provider relationships, and participation in CRO/vendor selection for Data Management services and software
  • Oversight of data management vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
  • Oversight of key documents such as data validation specifications and programs, manual data review guidelines, computerized edit check programs, Data Management Plans (DMP), etc…
  • Work closely with Statistics & Programming to ensure high quality data output including data cleaning/validation, SAS listings review, TLF dry runs, etc
  • Develop, track, analyze, and report on internal data management performance metrics
  • Contributes to back-end project budget/resource planning, re-forecasting, program milestones, along with CPMs and Clinical Operations management
  • Bachelor’s in Science and/or Computer Systems/IT background; MBA, advanced degree and/or PMP Certification strongly preferred
  • Minimum 15 years (5 years management/leadership) experience in a pharmaceutical/biotech setting preferred
  • Advanced experience in CRO and vendor oversight in fully outsourced or FSP resource models
  • Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, CDISC requirements
  • Strong leadership skills and ability to work within cross-functional teams
16

Clinical Data Management Resume Examples & Samples

  • Manage day-to-day operations of assigned studies
  • Responsible for planning, assigning, and reviewing work performed by Data Managers and FSP teams
  • Manage data management communication and provide conflict resolution for any data management issues that may arise during the study
  • Create, review, and approve study documentation following GxP and sponsor’s policies, guidelines, and procedures
  • Manage relationships with external vendors as well as consultants/functional service providers assisting in the study
  • Collaborate with other LDMs to discuss issues and identify solutions across therapeutic areas
  • Ensure successful, timely and cost effective development and implementation of high quality deliverables
  • Ensure adherence to standard operating procedures and working practices for assigned projects
  • Participate in development, defining, maintenance, and enforcement of standards
  • Train, monitor, and mentor Data Managers as required for assigned projects
  • Assigning work, reviewing work, and Planning other’s work
  • Expertise in time and resource management required
  • Good organizational skills with great attention to detail and the ability to multitask
  • Ability to delegate, assign, and monitor workflow
  • Capable of leading teams and working collaboratively in a team environment
17

Associate Director, Clinical Data Management Resume Examples & Samples

  • 9 years of experience and a BS degree
  • 7 years of experience and a MS degree
  • 5years of experience and a PhD
18

Senior Clinical Data Management Associate Resume Examples & Samples

  • 5 years of experience and a BS degree
  • 3 years of experience and a MS degree
  • 2 years of experience and a PhD
19

Associate Director Clinical Data Management Resume Examples & Samples

  • Represent Clinical Data Management at cross-functional forums, meetings and provide timely feedback to partners
  • Lead and support clinical & non-clinical special projects
  • Support the establishment of training programs (technical and professional skills) for Clinical Data Management staff and ensure staff training is conducted and properly documented
  • If required, deputize for the responsibilities of the Operational/Functional Manager
  • Ensures that there is adequate and appropriate resources to manage the study for Clini-cal Data Management activities
  • Provides all necessary support to address any issues requiring management input
  • Represents the group in any forums including leadership team meeting to address issues. Ensure process improvements suggestions are evaluated and support team to bring suggestion to management for consideration
  • Provides management oversight for all the activities for Clinical Data Management during study startup
  • Authorizes the GoLive based on a review of completion of all activities for pivotal trials
  • Provides management oversight for all the activities for Clinical Data Management during data finalization
  • Ensure data finalization activities are appropriately managed for pivotal trials
  • Provides management oversight for all the activities for Clinical Data Management for optimization of data quality management and accurate reporting of statuses
  • Liaise with Operations and Central Services team to address any issues in the reporting of metrics
  • Provides management oversight for all the activities for Clinical Data Management for the management of third party data
  • Liaise with Operations and Central Services and outsourcing management teams to ad-dress any issues of 3rd party vendor management and CRO partners
  • Ensures that the group including managers has completed all their training requirements
  • Ensures that the associates are fully applying the GCP Principles, DM Standards, SOPs/WPs and process guidelines
  • Participates in Health Authority inspections as required
  • Ensures that each associate has an up to date training and development plan in place
  • Ensures adequate resources are in place for the management of programs
  • Reports to Director if there are any additional unanticipated demand for resources for activities such as post-submission activities
  • Ideally 10 or more years’ experience in drug development with at least 8 years in Clinical Data Management
  • Strong technical and problem solving skills, and ability to evaluate computer systems for Data Management
  • Excellent understanding of clinical trials methodology, GCP and medical terminology
20

Senior Mgr / AD, Clinical Data Management Resume Examples & Samples

  • Manage CDAs efficiently across studies by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews.Perform hiring and training activities as needed
  • Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product.Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
  • Independently develop and manage the development of DM deliverables including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications and Data Review Plans. Ability to run SAS programs, review SAS logs, and generate output.Program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level.Mentor less proficient SAS users as appropriate
  • Independently lead data cleaning activities such as but not limited to Study Team data reviews, SAE reconciliation and non-CRF data reconciliation
  • Independently manage the database lock process in an efficient and timely manner
  • DM Project Management: Understands critical tasks and milestones; ensures data management deliverables are met per study timelines.Assist DM Management in coordinating and/or supervising data management activities across studies
  • Ability to research, evaluate and lead departmental initiatives and new technologies/innovations to improve CDM processes; represent CDM through working groups (internal and external) and initiatives where thorough knowledge of CDM practices/processes are required
  • Lead the Data Standards Committee (DSC) through role as DSC Chair. Support implementation of data standards
  • Responsible for oversight of Centralized Monitoring and support of expansion of centralized monitoring efforts within Data Management
  • Serve as liaison between Data Management and Clinical Information Systems to support infrastructure development and improvements
  • Serve as liaison between Data Management and Biometrics
  • BA/BS in relevant field and 10+ years experience and 5+ years management experience
  • Requires effective organizational and communication skills
  • Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession
  • Detail oriented; performs quality and accurate work
  • Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
  • SAS programming experience; ability to program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings.Mentor less proficient SAS users as appropriate
  • Previous vendor/CRO management required
  • Previous management experience is required
  • Thorough knowledge of the database development process
  • Strong experience and knowledge in the application of data standards
  • Excellent supervisory, problem solving, negotiation and organizational skills
21

Senior Mgr Clinical Data Management Resume Examples & Samples

  • Management of clinical data vendors to achieve the productivity, quality, and timelines requirements of projects
  • Maintaining optimal department processes and implementing excellent project-specific strategies
  • Technical data management leadership or oversight on global, large and/or multiple projects
  • Responsible for the development of project Data Management Plan(s); data management systems set-up, data accession, data entry and data review specifications and processes
  • Technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project(s) timelines and budgets
  • Develop and maintain a close liaison with project client contacts, core team members and Project Managers
  • Minimum seven (7) years relevant work experience in data management with four (4) years technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas
  • Demonstrated skill for technical and supervisory leadership of 8-15 staff within one or more locations in a region
  • Excellent oral and written communicat ion and presentation skills
  • In depth knowledge of clinical trial process and data management, clinical operations,
  • In depth knowledge of tracking of staff productivity and quality metrics
  • Demonstrated skill for mentoring and developing staff on technical and core competencies
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical biotechnological companies
  • Operational experience in other disciplines such as clinical, biometrics, medical writing, pharmacovigilance, safety, quality assurance, regulatory, etc
  • Demonstrated ability to lead by example teams on strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions
  • Strong leadership and interpersonal skills
22

Senior Manager / AD Clinical Data Management Resume Examples & Samples

  • Oversees the Clinical Data Management Department, with direct supervisory responsibilities for all in-house and external data management personnel (e.g., contractors and functional service providers)
  • Supervises CRO data management activities, including evaluating and selecting CRO vendors and tracking quality of CRO data management performance
  • Oversees third party data integration, from selection of vendor to review of data to final deliverable
  • Collaborates and coordinates with study team members to assist in the design, review and creation of high-quality clinical protocols
  • Develops systems for organizing data to analyze, identify and report data and trends
  • Designs on-line case report forms for EDC data management system
  • Creates Data Validation Specifications
  • Creates eCRF Completion Instructions
  • Executes study specific procedures compliant with Regulatory and internal requirements
  • Represents Clinical Data Management in project team meetings
  • Reviews the Tables, Listings and Figures
  • Supports the generation of clinical study reports
  • Establishes timelines for assigned projects
  • Works extensively with project leaders, clinical team members and CROs
  • Interacts with functional groups that are contributing to the clinical data management plan
  • Liaise with clinical, safety and regulatory organizations for coordination of global activities
  • Trains appropriate team members on department SOP’s and identifies gaps in current processes and develops solutions
  • Develops and maintains department standards (e.g., SOPs)
  • Member of Biostatistics and Data Management
23

Clinical Data Management Intern Resume Examples & Samples

  • Understand Clinical Trial Process
  • Clinical Trial lifecycle – Protocol to Database delivery
  • Clinical Database Development / Specifications
  • Understanding of project timelines
  • Clinical Data Management tools and processes
  • Develop & QC Reports (either standard or study-specific)
  • Have the conceptual understanding to be able to question why processes are as they are and put forward thoughts of improvement whilst considering impact on current activities
  • Understand the need for focus & detailed working, but also seeing the process as a whole
  • Recognise the importance of having a well balanced team and how each individual contributes differently
  • Identify which area / department / skill-set the individual would like to develop for future employment
  • An interest in the Pharmaceutical industry, clinical trial and drug development process
  • Ideally looking for someone with SharePoint knowledge
  • A good technical ability desirable
  • Strong grasp of basic Microsoft tools (word/excel/outlook etc) is required
  • Critical thinking and attention to detail
24

Senior Specialist, Clinical Data Management Resume Examples & Samples

  • Oversee the successful execution of the Patient Reported Outcomes strategy for one or more programs, providing end-to-end technical project management support to clinical project teams and ensuring that all aspects of the Patient Reported Outcomes project plan (from protocol initiation through system closeout) are executed on time, and with highest standards of quality
  • Ensure that vendors are planning and managing timelines and employing risk management techniques across all programs
  • Have operational visibility across all studies in a particular therapy area of focus
  • Monitor execution of the system development process from kickoff to system go-live, ongoing system change control, system closeout and database lock activities; perform cost / benefit analysis for projects, as appropriate
  • Develop vendor-specific strategies for Patient Reported Outcome projects and provide input to cross-vendor project strategies; and manage vendor performance and relationship(s)
  • Define and implement process with vendor representatives, monitoring and analyzing vendor and Merck performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues
  • Develop and maintain relevant documentation, including applicable Standard Operating Procedure, job aids, and guidance documents
  • Define process in collaboration with stakeholders and manage implementation plans
  • Function in the Patient Reported Outcome SME role independently and work to resolve conflicts that are complex, cross departmental, or external to Merck
  • Independently prioritize work activities to align with team objectives and current activities
  • Provide training and education for stakeholders; and serve as project or program manager of all Patient Reported Outcome activities for projects assigned
25

Director, Clinical Data Management Resume Examples & Samples

  • Lead the CDM function at Frontage Clinical Services to maintain customer satisfaction and promote employee engagement
  • Supervise, coach, and mentor the staff of CDM
  • Willing to maintain regular office hours in either our Secaucus or Somerset, NJ offices
  • Stay up-to-date on topics in data management in order to inform the organization, ensure regulatory compliance, and to adopt newly available technologies in a timely fashion
  • Create, review, and update CDM processes and Standard Operating Procedures
  • Develop metrics for assessment of CDM performance and regularly assess the performance for those metrics
  • Review and evaluate data management plans for study implementation
  • Ensure that study report tables, graphs, and data listings are produced with the highest level of quality
  • Direct the design of databases and validation of edit and range checks for those databases
  • Manage development and review of case report forms and annotated case report forms
  • Supervise entry and assignment of MedDRA and WHODrug codes into database through cooperation with drug safety personnel
  • Cooperate on the delivery of datasets for statistical contributions to study reports and integrated summaries for pharmacokinetic, efficacy, and safety analyses
  • Interact with other project team members and clients
  • Support Business Development activities related to CDM
  • Minimum of a Bachelor’s degree in a biomedical or computer science discipline, or equivalent training is required
  • At least 10 years of experience in data management in a clinical research environment; early phase clinical experience preferred
  • Clinical database management skills necessary
  • At least 3 years of managing direct reports required
  • Experienced in working with EDC systems and vendors
  • Proficient in computer skills (word processing, spreadsheets, graphing software)
  • Expert knowledge of medical and data management terminology
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Director, Clinical Data Management Resume Examples & Samples

  • Bachelor’s degree in Health Science, Pharmacy or Life Sciences from accredited college or university. . Advanced degree preferred
  • Minimum of 10 years of Data Management and Clinical Trial experience in the Biotech/Pharma/CRO industry
  • Minimum 10 years of line management and project team leadership experience, as well as process management and innovation
  • Prior experience with clinical trials leading to NDA submissions. Prior engagement with NDA eSubmission
  • Demonstrated strong technical and problem solving skills
  • Excellent written and verbal English communications skills, including presentation skills
  • Excellent MSOffice skills including Word, Excel, PowerPoint, Outlook
  • Demonstrated team management skills
  • Proven ability to manage multiple projects, set priorities and meet deadlines
  • Ability to work well on a team and independently
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Head, Clinical Data Management Resume Examples & Samples

  • Develop data collection standards for Moderna
  • Develop best practices for data handling
  • Consult with CROs to solve operational data issues and maintain vendor oversight
  • Work effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools
  • Manage clinical trial data through oversight of cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements
  • Ensure timing and integrity of data transfers from all vendors
  • Review data analysis listings and report on performance and quality
  • Review clinical data within studies and across for trend analysis
  • Support the strategy for data cleaning to ensure timely deliverables
  • Support the data collection through efficient eCRF and database design
  • At least five years of management experience in a clinical research environment, most of which should be in industry and preferably across therapeutic areas
  • At least 10 years of clinical data management experience in industry, with experience across indications and EDC platforms
  • Multi-faceted background devising plans for operational challenges such as site EDC training, preparing cohorts for data review in dose escalation, vendor oversight, protocol deviation management, data cleaning, etc
  • Cross Collaboration proficiency with other functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
  • Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills
  • Early and late development experience
  • Vendor management and oversight experience
  • Strong technical skills across data platforms
  • Experience with Spotfire or other data visualization software
  • Bachelor’s Degree in a science-based subject
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Associate Director, Clinical Data Management Resume Examples & Samples

  • Responsible for ensuring that Data Management SOPs, Work Instructions and Templates represent current industry practices, Regulatory guidelines and standards
  • Oversight of build, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements
  • Bachelor’s in Science and/or Computer Systems/IT background; MBA, advanced degree and/or PMP Certification required
  • Minimum 10 years experience in a pharmaceutical/biotech setting preferred
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Intern, Clinical Data Management Resume Examples & Samples

  • Has basic understanding of relational database elements: tables, variables, variable properties
  • Can understand and execute test script instructions, can understand simple edit check conditions (e.g. interval and range checks). Can evaluate if a tested item has failed based on test script of Testing instructions. Can effectively communicate test failures to database developers
  • Can understand regulatory requirements for Clinical Data Management documentation
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Data Team Lead, Clinical Data Management Resume Examples & Samples

  • Project management of all data management through to completion
  • Providing this expertise to customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and technical expertise
  • Managing and organizing data so that it is accessible and sufficiently well summarized for customer and regulatory bodies such as the FDA
  • Acting as a point of contact for various stakeholders including customers and the Clinical Data Management team, as well as working closely with the data programmers
  • Understanding the components of a study start up through to study close out, and developing key documentation
  • Creating and working with a supportive team environment, and sourcing candidates who will contribute to the expected high standards
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Director, Clinical Data Management Resume Examples & Samples

  • Leads and oversees Clinical Data Management function and EDC programming (through external vendors)
  • Provides leadership within Clinical Data Management by collaborating with internal and external stakeholders to optimize data management technology, processes and standards and to enable successful execution of corporate objectives
  • Identifies ways to continuously improve all aspects of data management and implements solutions; strengthens and enhances the data management service, operations, and execution
  • Coaches, develops and provides continuous feedback to a team of direct reports / Provide guidance and direction to ensure departmental and client/project goals are met
  • Responsible for hiring, training, development and management of staff; ensures effective resource allocation
  • Serves as the lead liaison to internal and external clients
  • Develops and tracks metrics on productivity and quality and creates strategies and best practices to increase efficiency and quality
  • Responsible for overseeing all data management activities leading up to and including interim and/or final database locks inclusive of interacting with the appropriate cross-functional staff: Clinical Operations, Biostatistics and programming to meet Company’s objectives
  • Develops departmental policy, standard operating procedures, and work instructions
  • Ensures that standards are applied across studies (EDC Builds, CRFs, CRF Completion Manuals, Edit Checks, etc.)
  • Oversee the development and validation EDC study builds and the associated data listings, reports, data transfers and detailed timelines
  • Monitors data management workflow and tracks project metrics
  • Defines CRF standards, oversees individual study CRF design and production
  • Develops department goals and objectives and implements plans to meet the them
  • Manages department budget development to forecast
  • Identifies need for external support; negotiates agreements to secure contract staff and/or vendors
  • Oversees selection and management of study vendors
  • Leads strategic planning and execution of the department’s objectives including timeline and budget projections, risk mitigation strategies, and data management governance
  • Effectively interfaces with Senior Management and other functional areas to assure coordinated expectations and deliverables from Clinical Data Management
  • Ensures that the clinical programs are executed in compliance with ICH Guidelines, GCP and CRF Part 11, and any other local requirements
  • Bachelor’s Degree; advanced degree in related field preferred
  • Minimum of fifteen (15) years of relevant data management experience, including five (5) years in a supervisory role, either as a functional/line manager or co-accountable for performance management within a team matrix, or combination of equivalent experience
  • Comprehensive knowledge of GCP, ICH, CFR Part 11 and computer systems validation; sufficient knowledge of Competent Authority regulations in regions outside the US
  • Proficiency with web-based EDC systems
  • Experience with medical coding preferred
  • Experience with SAS programing preferred
  • Demonstrated knowledge in several relevant therapeutic areas
  • Advanced computer skills in Word, Excel, PowerPoint, and MS Project
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Clinical Data Management Associate Resume Examples & Samples

  • Assist in the development of study Data Management Plan, including Edit Check Specifications, eCRF completion guidelines, and /or required data management documentations and raise queries to resolve erroneous, missing, incomplete or implausible data
  • Perform data review and query management to ensure that quality standards are archived
  • Generate, resolve and track queries to address problematic data identified during aggregate data review activates and apply proper modification/correction to the database as required
  • Create test scripts from Edit Check Specifications to test edit checks and to test database screen functionality
  • Assist in reconciling AE/SAE data in Clinical Data Management Database with Medical Monitor
  • Assist the Data Management team with all data management activates from study start-up to database lock
  • Oversee and supports data acquisition from external sources
  • Manage vendor performance and deliverables according to the Scope of Work to ensure quality and timelines if applicable
  • Provide input the development of departmental standards and operating procedures
  • File Data Management documentation and execute Data Management related administrative tasks as requested, including maintenance of TMF as required
  • Perform any other duties as assigned
  • Education: Bachelor Degree in Science or Business related field and/or equivalent work experience
  • Experience: A Minimum of 2 years of Data Management experience to include essential duties above within a pharmaceutical, medical device, biotech or CRO required
  • The preferred candidate must have strong writing, verbal communication skills and organizational skills
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Director, Clinical Data Management Resume Examples & Samples

  • Lead the CDM function at Frontage Clinical Services to maintain customer satisfaction and promote employee engagement Supervise, coach, and mentor the staff of CDM
  • Create, review, and update CDM processes and Standard Operating Procedures Develop metrics for assessment of CDM performance and regularly assess the performance for those metrics
  • Ensure that study report tables, graphs, and data listings are produced with the highest level of quality Direct the design of databases and validation of edit and range checks for those databases Manage development and review of case report forms and annotated case report forms
  • Cooperate on the delivery of datasets for statistical contributions to study reports and integrated summaries for pharmacokinetic, efficacy, and safety analyses Interact with other project team members and clients
  • Support Business Development activities related to CD
  • At least 10 years of experience in data management in a clinical research environment; early phase clinical experience preferred Clinical database management skills necessary
  • At least 3 years of managing direct reports required Experienced in working with EDC systems and vendors Proficient in computer skills (word processing, spreadsheets, graphing software)
  • Excellent verbal and written communication skills Expert knowledge of medical and data management terminology
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Specialist, Clinical Data Management Resume Examples & Samples

  • Serves as project manager of all IRT & COA systems activities for protocols assigned. Uses interpersonal, negotiating, and project management skills to perform the following tasks
  • Provides support for successful integration of Merck and vendor systems
  • Provides support for problem resolution between IRT & COA systems vendors and Merck Clinical Trial Team
  • May assist in development of, reference and/or training material
  • May support a continuous improvement special project or any other project or perform any other IRT & COA systems related task deemed appropriate by management
  • 4 years’ experience in Clinical Data Management with at least 2 years’ of IRT Systems and/or COA working experience
  • Demonstrate knowledge of IRT & COA systems development processes
  • Knowledge of the clinical development process, preferably through submission; thorough knowledge of clinical data management
  • Solid experiences in study start up activities for EDC Inform/ IRT Systems/ COA (paper & e)
  • Demonstrated project management skills; strong organizational, communication, and problem-solving skills
  • Experience working with external vendors
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Associate Director, Clinical Data Management Resume Examples & Samples

  • Participates in recruiting efforts
  • Directs the activities of CDM team members to complete project deliverables on schedule and according to quality standards, and requirements from study start-up through archival
  • Contributes to performance reviews of project team members
  • Ensures projects are conducted in compliance with operating procedures and good clinical practices
  • Review and provide input for reports and clinical documents such as clinical protocols, informed consent, Investigator Brochure, yearly updates to the regulatory authorities and status updates
  • Participate in cross-functional initiative teams
  • Represents data management on project teams and manages scheduling and time constraints across multiple projects/resources
  • Recommends alternative work processes to improve the quality or speed of internal customer deliverables and responds to customer/team questions on CDM process, timelines and data quality
  • Communicates and escalates project level issues including processes, timelines, resourcing, performance, etc. and establish appropriate course of action with Senior Management
  • Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
  • Assist in preparation and support of clinical documentation for IND and NDA submissions as appropriate
  • Support regulatory submission activities for assigned projects
  • Minimum of 7 -10 years in pharma or CRO industry, with minimum of 5 years in hands on leadership functional/line role
  • At least 5 years of recent Oncology trials data management experience is required
  • Proficiency in Microsoft Office tools
  • Experience using clinical data management systems and/or EDC products (e.g. RAVE, Inform, Oracle Clinical/RDC, etc.)
  • Track record of completed deliverables on time and adjust priorities in a fast paced environment
  • Has worked independently as well as collaboratively in a team environment
  • Strong experience in CRO and vendor management for global clinical trials
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Associate Director, Clinical Data Management Resume Examples & Samples

  • Bachelor’s degree or above in a biomedical or computer science discipline or equivalent experience is required
  • Must be proficient in computer skills (word processing, spreadsheets, scientific graphing software)
  • Knowledge of medical and data management terminology essential
  • At least 5 years of experience in data management in a clinical research environment
  • Database management skills necessary
  • Assist in the preparation of statistical contributions to study reports and integrated summaries for pharmacokinetic, pharmacodynamic, efficacy and safety analyses Interact with other project team members and clients Assist BD activities related to DM