Senior Clinical Data Manager

About the role

Job Summary: The Senior Clinical Data Manager is responsible for all aspects of the data management process, from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine data review, through database lock of clinical trials. The Sr/CDM has a broad, fundamental knowledge of the data management process and can plan, manage, and coordinate all Data Management activities for assigned study(ies) with minimal guidance. This person may have project-level oversight of junior data managers and/or Clinical Data Associates (CDAs). The core duties and responsibilities of the Sr/CDM are delineated below.

Location: Redwood City, CA - Hybrid. W2 Contract.

Responsibilities

• Represents data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate.
• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.
• 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.
• Provides oversight of database set-up/migrations/updates, including coordinating and performing UAT.
• Leads the development of the internal Data Review Plan and coordinates the cross-functional team data listing review.
• Coordinates the internal medical coding review.
• Performs ad hoc and scheduled 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.
• Executes and/or distributes data management metrics, listings, and reports.
• Provides oversight of data management CRO/service providers, including managing and monitoring the progress of data management activities with CROs and/or other service providers on assigned studies; builds effective relationships with CRO/service provider counterparts.
• Reviews and provides feedback to the clinical team on other study documents, e.g., Clinical Monitoring plans and vendor specifications.
• Provides training on the EDC system and/or CRF completion guidelines and the EDC system to internal or external study team members, as needed.
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Maintains study DM related documents/files for inspection readiness.
• Provides DM support to Statisticians and Statistical Programmers in the production of clinical trial reports and other deliverables.
• Assists with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).
• Participates in the CRO/vendor selection process for outsourced activities.
• Supports budget and resource planning across assigned projects.
• Participates in the development, review, and implementation of departmental SOPs, templates, and processes.
• Participates in