Clinical Data Management Job Description

Clinical Data Management Job Description

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Clinical data management provides leadership, Mentoring and Training for data management staff on good data management practices, standard operating procedures, and clinical science.

Clinical Data Management Duties & Responsibilities

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

Sample responsibilities for this position include:

Gain a solid understanding of GCP
Manage clinical trial documentation such as CRFs (case report forms) and DCFs (data clarification files) within Data Management
Accountable for all data management deliverables within their therapeutic area(s) (Neurosciences and Diabetes)
Keeps abreast of new developments in the area of clinical data collection, processing, storage, and retrieval in order to provide guidance in the selection, enhancement, and maintenance of data management tools and processes
Responsible for the development of project Data Management Plan(s)
Ensures data management problems are identified early in the lifecycle and are followed through to resolution
Manages vendors for systems and software used by Data Management
Serves as Project Manager for studies with only Data Management services
Ensures all deliverables are on time and on budget for all data management projects
Performs data review in support of data cleaning, including review of data listings, exception reports, and patient profiles

Clinical Data Management Qualifications

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

Licensing or Certifications for Clinical Data Management

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

Education for Clinical Data Management

Typically a job would require a certain level of education.

Employers hiring for the 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, Management, Project Management, Education, Life Sciences, Life Science, Science, Nursing, Health, Pharmacy

Skills for Clinical Data Management

Desired skills for clinical data management include:

GCP
FDA
Medical terminology
Clinical research
Clinical data management and the clinical trial process
Data Management processes and systems
ICH
Data management
Clinical Drug Development Process
Good Clinical Practices and applicable Standard Operating Procedures

Desired experience for clinical data management includes:

Familiarity with Electronic Data Capture (EDC) systems - Medidata Rave highly preferred
Java script programming and C# experience preferred
Familiarity with Operational Qualification/Performance Qualification and UAT (User Acceptance testing) execution and documentation
Bachelor’s degree or equivalent required, preferably in the Life Sciences, , Biology, Chemistry, Biochemistry, Nursing, Pharmacy
Supports CDMs with various study start-up activities, which may include protocol review, case report form (CRF) design, transfer and edit check specifications review, and user acceptance testing (UAT) of electronic data capture (EDC) systems
BA/BS degree in Biological Science or a related discipline in the science/health care field or equivalent education and experience

Clinical Data Management Examples

1

Clinical Data Management Job Description

Job Description Example
Our company is hiring for a 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 clinical data management
  • Identifies ways to continuously improve all aspects of data management and implements solutions
  • Support the team in their communication with stakeholders
  • Support the Clinical Programmer(s) in their key responsibilities
  • Under supervised training and mentoring, gradually assume responsibility for agreed tasks
  • Shadow colleagues and gain a solid understanding of all roles in CDM
  • Complete a learning assignment and present the outcome to CDM management
  • Develops direct reports, sets challenging objectives aligned with company and organizational goals, conducts periodic skill assessments annual performance appraisals, coaches for performance and employee development, provides ongoing feedback on performance, provides rewards and recognition, and sets priorities
  • Forecasts short and long term resource needs, establishes measures to improve their area’s effectiveness and efficiency
  • Manages travel, training and other expenses for their staff
  • May lead or provide direction to continuous improvement or any other project as deemed appropriate
Qualifications for clinical data management
  • Experience in a Contract Research Organization or pharmaceutical/biotechnology company preferred
  • An appreciation of Project Management skills preferred
  • Ability to work effectively within a team matrix independently
  • Experience successfully working in a team environment with faculty, students, clinicians and staff
  • Excellent organizational, communication and interpersonal skills are necessary
  • AHIP [Academy of Health Information Professionals] certification preferred but not required
2

Clinical Data Management Job Description

Job Description Example
Our company is growing rapidly and is looking for a 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 clinical data management
  • Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
  • Oversees the planning and management of external Data Management budgets (in collaboration with Clinical Operations TA Leads) to ensure accuracy, understand trends in variances and support continuous improvement in forecasting
  • Act as the Lead data management team member in clinical development
  • Perform or support data management activities for multiple studies in different indications
  • May serve as a Data Management Customer Liaison for customers
  • Provides leadership, mentorship to internal data management staff
  • Ensures the integrity of data, providing recommendations for corrective action when necessary
  • Keeps management abreast of issues, progress, and risks related to trial operations
  • Stay current and knowledgeable about best practices in clinical management processes (case management, concurrent review, medical necessity review, ) within payers and within providers who have delegated financial risk
  • Review data analysis of existing processes
Qualifications for clinical data management
  • Bachelor’s in Science and/or Computer Systems/IT background
  • Demonstrates a working understanding of the research process and familiarity with research design and methods
  • Demonstrates a working understanding of ETL and process mapping
  • An understanding of the delivery of health care and the varied systems in which data can be collected
  • Provide strategic direction for the development and piloting data collection tools
  • Demonstrates a thorough understanding of SQL, Tableau, and MS Access queries, reports, and forms
3

Clinical Data Management Job Description

Job Description Example
Our innovative and growing company is looking for a 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 clinical data management
  • Maintain data management and programming acumen in clinical research through education, programs, lectures and publications
  • Provide oversight, leadership and direction in data management and programming services
  • Manage data management and programming personnel
  • Manage vendors and vendor contracts associated with data management systems and activities
  • Represent data management and programming at business development/customer meetings and audits
  • Understand and apply regulatory guidelines/developments and industry standards/best practices in data management and programming
  • Help perform program efficacy analyses
  • Serve as the go-to resource for how clinical management processes are traditionally structured, including who does what, data used to conduct clinical management tasks, etc
  • Perform stakeholder engagement and communication to help test and refine requirements
  • Identify process improvements, based on available data, role objectives and program outcomes
Qualifications for clinical data management
  • Demonstrates a strong competence in univariate and basic multivariate statistics
  • Interprets, summarizes, and reviews process control analysis of various projects as needed
  • Responsible for the department delivering datasets free of identifiable defects
  • Demonstrates proficiency in statistical tools used in Tabluea
  • Demonstrates the ability to collaborate and communicate well with all members of the healthcare team at all levels of the organization
  • Demonstrates the ability to take direction well
4

Clinical Data Management Job Description

Job Description Example
Our growing company is looking to fill the role of 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 clinical data management
  • Serves as Clinical Data Management Project Manager by providing leadership and management of data management activities
  • Define the strategy of the Data Management group by identifying innovations (IT, standardization, organizational) that could lead to the efficiency and increase the quality of the whole department
  • Coordinate complex data management tasks with high level of autonomy and ensures the activities performed throughout a trial are compliant with current guidelines and process
  • Provide critical reviews and inputs linked to the data management aspects for development of Clinical Evidence Plan and Protocol Outline at the early stage of development
  • Evaluates Data Management outsourced activities to ensure efficiency and regulatory compliance
  • Support clinical studies including CRF design/review, database build and validation, creation of data management documents and laptop setups
  • Manage and contribute to the review of current practices and procedures, to ensure that all data management activities are completed to applicable regulatory policies and standards
  • Work with clinical analysts and platform developers to structure improved clinical management workflow
  • Participate in sprints with multi-functional team to translate optimized workflows into actual system functionality
  • Work in sprints with multi-functional team to help test and validate optimized clinical management workflows
Qualifications for clinical data management
  • Master's degree or higher is required
  • Familiarity with healthcare environment and healthcare performance measurement required
  • Knowledge of, and ability to interpret, univariate and basic multivariate statistics required
  • Proficiency with Lean and Six Sigma
  • Proficiency with CMS, State, TJC, third party payer quality data reporting requirements
  • Working understanding of the research cycle and research methods required
5

Clinical Data Management Job Description

Job Description Example
Our company is looking for a clinical data management. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical data management
  • Manage build and develop a highly effective team data management team aligned with the needs of the portfolio
  • Support the Data Acquisition Specialist(s) in their key responsibilities
  • Responsible for hiring, training, development and management of staff
  • Identifies need for external support
  • Promote understanding of the Mission and Core Values as it relates to quality improvement, patient safety and our patient experience
  • Provide technical project support for PAMC in meeting quality improvement goals and objectives which improve patient care across the care continuum, particularly where the ambulatory and hospital spheres overlap and patient care may be compromised
  • Identify and track quality metrics likely to be tied to national or regional performance measures of the hospital, the likely links to “pay for performance”, and work to support projects for improvement
  • Provide leadership for the continued development, growth, and refinement of the Clinical Data Warehouse (CDW)
  • Work collaboratively with leaders in an effort to ensure that key metrics are identified, defined, and tracked to better realize improvements in areas of providing safe, effective, compassionate, quality care
  • Proactively identify areas of unmet data and tracking needs in relation to process improvement projects, patient safety projects and everything affecting our patient/family experience
Qualifications for clinical data management
  • Excellent oral and written communication, organizational, and interpersonal skills required
  • At least 10 years Clinical Development Experience
  • At least 5 years’ experience in Clinical Data Management including full-life cycle (data collection through database lock and regulatory submission/ approval)
  • At least 5 years’ experience and demonstrated success in personnel management, either directly (line reporting) or in a matrix environment
  • Experience leading a large cross-functional team
  • Experience working with Alliances/Partners and CROs

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