Manager, Clinical Data Management Job Description
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:
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:
Desired experience for manager, clinical data management includes:
Manager, Clinical Data Management Examples
Manager, Clinical Data Management Job Description
- 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
- 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
Manager, Clinical Data Management Job Description
- 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
- 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
Manager, Clinical Data Management Job Description
- 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)
- 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)
Manager, Clinical Data Management Job Description
- 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
- 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
Manager, Clinical Data Management Job Description
- 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
- 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