Manager of Clinical Data Management

Role Summary

Lead and oversee end-to-end Clinical Data Management activities on assigned studies and programs. Serve as the subject-matter expert for Data Management and manage all third-party data sources, CRO oversight, timelines, and risk management. Collaborate with cross-functional groups within the data science teams. This role can be based at or near Salt Lake City or New York City.

Responsibilities

• Lead end-to-end data management activities, manage outsourced studies, and oversee DM and external vendor deliverables; proficient in managing 2-3 outsourced programs concurrently.
• Represent the Data Management function in Clinical Study Meetings, aligning CRO and Recursion expectations regarding all data-related deliverables.
• Collaborate with CRO and Recursion functional groups to complete EDC setup, database migrations/UAT, and other systems such as IRT and ePRO; routinely manage multiple vendor SFTP data retrieval and delivery to statistical programming.
• Establish Vendor Oversight Plans for all studies and be responsible for Vendor Data Quality Reviews and Oversight, aiming to harmonize processes with other Recursion clinical programs where relevant.
• Serve as an SME for operational DM activities and processes (EDC, external data standardization, collection, and processing); lead efforts with Biometrics and Clin Dev for creation and standardization of CRF’s Data Review Plans; provide study metrics and propose solutions for data handling.
• Lead the creation and maintenance of Data Management documents (CDMP, CCGs, Data Review Plans, edit checks, listing review checks, data integration specifications, data transfer specifications, external data reconciliation plans, SAE reconciliation guidelines, coding guidelines, database lock, checklists, and plans).
• Coordinate with other functional groups for submission-related activities.
• Provide strategic input on data flow design across EDC and non-EDC data sources across vendor networks.
• Ensure filing, archival, and inspection readiness of all Data Management TMF activities.

Qualifications

• Bachelor’s degree in science, math, or computer science.
• 8-12+ years’ experience in the biopharmaceutical industry; experience, technical proficiency, and people management skills determine the level.
• Experience managing external data and 3rd party vendors is a must.
• Strong knowledge of regulations and guidelines applicable to the conduct of clinical trials.
• Excellent written and verbal communication skills and ability to work collaboratively as part of a team.

Skills

• Project management and ability to lead 2-3 outsourced programs concurrently.
• Vendor management and collaboration with CROs and internal teams.
• Familiarity with EDC, IRT, ePRO, data standardization, collection, and processing.
• Ability to create and maintain Data Management documents such as CDMP, Data Review Plans, edit checks, data transfer specs, and reconciliation plans.