Manager, Clinical Data Manager Study Lead

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Serve as the DM study lead and the primary point of contact for clinical study teams and external partners, (e.g., external data vendors and CROs) for 1 or more complex studies within a given TA. Oversee all DM activities across all stages of the trial from study start-up through archiving.

• Provide a high level of expertise in data management to support clinical studies.
• Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
• Oversee the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock.
• Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA/WHO-DD coding.
• Support the transfer, locking, and archiving of study databases. Manage scheduling and time constrains across multiple projects.
• Prepare recommendations for new or improved processes for data management and data flow.
• Perform & document the oversight of CRO data management activities for assigned studies.
• Ensure the design, implementation and maintenance of electronic case report forms, clinical trial database and electronic edit checks are performed according to SOPs and WIs.
• Identify data quality, CRO performance, documentation, process execution gaps and is accountable for resolution.
• Document DM sponsor oversight activities from protocol review through study close-out.

Review and approve study documentation for assigned studies, (including, but not limited to):

• Data Management Plan or equivalent (includes: Data Review, Reconciliation and Cleaning, Coding, SAE Recon, Local Lab Handling activities for CRF and non-CRF data)
• Case Report Form and Completion Guidelines
• Validation specifications and data transfer specifications

This role requires

• Bachelor Degree or equivalent experience in Mathematics, Science or a related field with at least 7 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry
• Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness
• Review (IRR) compliance
• Follow through on gaps until resolution, escalating as necessary.
• Lead/oversee all data management deliverables for assigned studies:
• Ensure deliverable timelines are developed according to the business need and program objectives.
• Ensure snapshot/lock plans are developed and collaborate with the CST for review and approval.
• Ensure regular status updates with metrics are provided to CST.
• Provide program level input to & monitor deliverable timelines.
• Monitor data quality and assess progress of data issue remediation on an ongoing basis.
• Identify risks, propose mitigations, proactively escalate operational or DM vendor or DM CRO issues.
• May provide limited program level support for a small program with limited number of studies