Clinical Data Manager
- The Clinical Data Manager actively participates in all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), and routine data review through database lock of clinical trials.
- The CDM has a broad, fundamental knowledge of the data management process and can plan, manage, and coordinate activities for assigned tasks with minimal guidance.
- This person may have project level oversight as a study Lead Data Manager.
- The core duties and responsibilities of the CDM are delineated below.
- Manages data management duties to meet study timelines.
- Review and may distribute/coordinate data management metrics, listings, and reports.
- Performs scheduled and ad hoc data listing review and generates/resolves queries in EDC.
- Performs external data reconciliation against EDC.
- Performs Serious AE reconciliation according to SOPs and guidelines, as applicable.
- Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
- Generates and/or reviews/approves study documents (e.g., Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols).
- Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors' systems.
- Reviews and provide feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.
- Maintains study DM related documents/files for inspection readiness.
- May oversee data management CRO/service providers including manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts.
- May assist with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).
- May participate in CRO/vendor selection process for outsourced activities.
- May participate in the development, review and implementation of departmental SOPs, templates, and processes.
- Contributes to a professional working environment through exemplifying Core Values.
- Bachelor's degree.
- At least three (3) years of CDM of Data Management experience in the pharmaceutical, biotechnology, or CRO industry; depth and exposure to DM related tasks considered in lieu of minimum requirement.
- Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
- Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
- Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
- Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
- Ability to handle multiple project tasks and prioritize effectively.
- Well organized and detail oriented.
- Proven ability to work both independently and in a team setting.
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