Manager, Clinical Data Management Job Description

Manager, Clinical Data Management Job Description

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Manager, clinical data management provides clinical support for projects according to Standard Operating Procedures, ICH Guidelines and GCP;.

Manager, Clinical Data Management Duties & Responsibilities

To write an effective manager, clinical data management job description, begin by listing detailed duties, responsibilities and expectations. We have included manager, clinical data management job description templates that you can modify and use.

Sample responsibilities for this position include:

Familiarity with clinical data management systems and industry wide thesauri, such as MedDRA, WHO Drug, J-Drug
Support data management activities for multiple studies in different indications
Manages data management related timelines and resources
Advance Data Management technical capabilities through refinement of existing processes and use new technology to develop prototypes to drive forward efficiency, map data relationships
Design, implement and oversee clinical data management training plans for research staff
Reviews and approves Data Management Plans for all trials
Ensures resources are trained and available for all data management projects
Manages data management colleagues including hiring, performance management training, and resource allocation
Represents Data Management with sponsors for business development activities
Liaise with cross functional team and external contacts to execute all aspects of data management trial delivery

Manager, Clinical Data Management Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Manager, Clinical Data Management

List any licenses or certifications required by the position: SAS, SCDM

Education for Manager, Clinical Data Management

Typically a job would require a certain level of education.

Employers hiring for the manager, clinical data management job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Computer Science, Project Management, Education, Management, Science, Life Sciences, Life Science, Nursing, Biology, Allied Health

Skills for Manager, Clinical Data Management

Desired skills for manager, clinical data management include:

GCP
Data Management processes and systems
Good Clinical Practices and applicable Standard Operating Procedures
FDA
Data management
Clinical Drug Development Process
EMA
FDA/ICH guidelines and industry standard practices regarding data management
ICH guidelines and regulations covering clinical trials
ICH/GCP regulatory requirements for clinical studies

Desired experience for manager, clinical data management includes:

Flexibility and ability to work on several assignments simultaneously
Designs Electronic Data Capture (EDC) databases to collect and process CRF data
4 year degree preferably in biologic sciences
Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution
Ability to forecast project resourcing and hours needed
Moderate mobility required

Manager, Clinical Data Management Examples

1

Manager, Clinical Data Management Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of manager, clinical data management. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for manager, clinical data management
  • Oversee Data Management vendors – review and approve all DM documentation
  • Manage Data Management function
  • Ensures data management processes are efficient and result in high quality output
  • Ensures data management processes follow SOPs and meet regulatory guidelines
  • Ensures data management staff provides excellent customer service both internally and externally
  • Responsible for ensuring deliverables on time and on budget for all data management projects
  • Project technical oversight of Data Management tasks for all programs
  • Create internal data quality checks in support of Data Management activities utilizing SAS and other clinical database programs
  • Clinical Study Data Management Execution
  • Manage a team of professional Data Management staff
Qualifications for manager, clinical data management
  • Able to communicate information and ideas so others will understand
  • At least 1 year of related experience in clinical research
  • Collaborate with cross-functional individuals from Clinical Operations, Clinical Development, Medical Affairs, Regulatory, Project Management, and CMC in support of project deliverables and regulatory needs
  • Review data transfers for consistency with available specifications, SDTM specifications, annotated CRFs
  • Contributes to development of outsourcing strategies and relationships with outsourcing partners or CROs
  • Minimum of BS preferably in Health Sciences, Statistics, MIS or Computer Science
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Manager, Clinical Data Management Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of manager, clinical data management. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, clinical data management
  • Provide hands-on support for computer systems validation documentation
  • Reviews and approves Case Report Forms and Completion Guidelines for all trials
  • Promotes and enforces responsible use of data standards
  • Builds and maintains relationships with programming team to ensure optimal performance
  • Drives efficiency by identifying and creating solutions and tools
  • Forecasts resources
  • Ensures database designs and data operations are consistent and conform to standard processes
  • Ensures proper documentation is filed in the Trial Master File
  • Participates in budget development both for projects and for the department budgets
  • Writes SOPs and Job Aids
Qualifications for manager, clinical data management
  • Thorough knowledge of applicable regulatory rules and ICH guidelines
  • Complex and/or international trials experience
  • Knowledge and qualification with international standards
  • Experience in managing and leading international meetings (Clinical Trial Team, expert meeting)
  • 1 year of related experience in clinical research OR Master's degree in Biology or Science related field
  • Seasoned knowledge and experience in the use of performance management techniques
3

Manager, Clinical Data Management Job Description

Job Description Example
Our company is growing rapidly and is looking for a manager, clinical data management. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manager, clinical data management
  • Adapts to and champions change, new tools, processes and technology
  • Possesses solid computer system and technical skills with a strong ability to learn multiple e computer applications
  • Responsible for promoting and enforcing responsible use of data standards
  • Builds and maintains relationships with programming support and systems support to ensure optimal performance
  • Writes SOPs and WPGs
  • Keeps management abreast of issues and progress on all assigned projects
  • Participate in vendor and technology (e.g., EDC) evaluation, qualification and selection
  • Provide CDM programming expertise for database set up, CRF design, and data cleaning to efficiently ensure high quality data
  • Collaborate with Statistical Programming as necessary to assist with data cleaning, trouble shooting activities
  • Assist with standardization of Case Report Forms including SAS naming conventions for all data received (external and clinical database)
Qualifications for manager, clinical data management
  • Minimum 6 years in Clinical Data Management
  • Deep understanding of clinical development and data management activities in order to understand the importance of data flow, data relationships, and corresponding system technologies
  • 8+ years’ experience of direct management of a program team/leadership
  • Certification for Project Management preferred previous leading / working within a Project Management Office (PMO)
  • Ability to create DM study documents (CRF guidelines, trial design documents, edit check specifications, data review plan)
  • Ability to update timelines using time management tools (@Task, MSProject)
4

Manager, Clinical Data Management Job Description

Job Description Example
Our company is hiring for a manager, clinical data management. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, clinical data management
  • Provide ongoing technical support of Medidata/RAVE during clinical trial conduct including development of clinical trials in EDC according to company standards
  • Provide ad-hoc report development, and support database lock and archiving activities
  • Oversight of a core DM Group
  • Management and development of DM employees within the core group
  • Assisting with recruitment of DM employees
  • Resource and budget planning for this core group
  • Planning, leading and overseeing DM activities for assigned products / projects
  • Contribute to and assist in the implementation of DM and the wider Global Study Operations Strategy
  • Provide technical and business expertise and leadership in process improvement activities and emerging technologies
  • Ensuring DM processes/systems meet regulatory and business requirements
Qualifications for manager, clinical data management
  • Bachelor’s degree in biology or science related field – or a Master’s degree in biology or science-related field in exchange for experience (below)
  • Manages custom query requests and reporting from clinical databases (i.e., Oracle Clinical, ) made by the Clinical department and other departments
  • Provides other departments with queries from clinical databases as necessary (e.g., Development, Marketing)
  • Remains current on developments in field(s) of expertise, regulatory requirements, and industry trends and trains staff regarding changing regulations that affect clinical studies
  • Advanced personal computer skills (experience with Microsoft Office or equivalent required) in graphics, word-processing, databases, authoring programs
  • At least six years of directly relevant experience of working within a highly regulated environment
5

Manager, Clinical Data Management Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of manager, clinical data management. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manager, clinical data management
  • Train new employees overall in data management processes
  • Possess knowledge of all other CDS procedural documents that impact Data Management
  • Assist with the recruitment of new staff to Data Management
  • Build and maintain good Data Management relationships across functional units
  • Contribute to and dive forward the strategic direction of DM globally
  • Lead and/or participate in cross functional working groups
  • Develop, review and implement policies, SOPs and associated documents affecting DM globally
  • Assist in responding to audit findings
  • Define and maintain SLAs and KPIs, including oversight or quality and CAPA management
  • Monitor progress of clinical projects, ensuring all are executed according to timelines with quality
Qualifications for manager, clinical data management
  • A flexible approach to process development
  • Knowledge of Good Clinical Data Management Practices
  • Clinical Data Management experience in clinical research industry (sponsor/CRO or combo)
  • 3+ years’ experience managing data solution projects
  • 3+ years’ managing STARS / HEDIS or Risk Adjustment Factor (RAF) data projects
  • 1+ years of experience with Clinical Data sets – bringing people together to solve problems using data

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