Manager of Clinical Data Management

Role Summary

Lead Clinical Data Manager responsible for end-to-end Clinical Data Management activities on assigned studies and programs. Manage 3rd party data sources and serve as subject-matter expert for Data Management. Collaborate on clinical development initiatives with cross-functional groups within the larger Data Science teams. Accountable for all CDM study activities and deliverables, document reviews, oversight of CROs, timelines, and project risk management; capable of handling multiple projects in a fast-paced environment. Location: Salt Lake City or New York City.

Responsibilities

• Lead end-to-end data management activities with hands-on ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables; proficient in managing 2-3 outsourced programs simultaneously.
• Represent Data Management in Clinical Study Meetings, ensuring proactive alignment of expectations between CROs and Recursion regarding data-related deliverables.
• Collaborate with CRO and Recursion functional groups to complete EDC setup, database migrations/UAT, and other systems such as IRT, ePRO; manage multiple vendor SFTPs for data retrieval and delivery to statistics programming.
• Establish Vendor Oversight Plans for all studies and be responsible for Vendor Data Quality Reviews and Oversight; harmonize processes across programs where relevant.
• Serve as SME for operational DM activities and processes (EDC, external data standardization, collection, processing); lead efforts with Biometrics and Clin Dev for CRF creation and standardization of Data Review Plans; provide study metrics and deliverables planning; propose data handling solutions.
• Lead/oversee the creation and maintenance of Data Management documents (CDMP, CCGs, Data Review Plans, edit checks, listing review checks, data integration specs, data transfer specs, external data reconciliation plans, SAE reconciliation guidelines, coding guidelines, database lock, checklists and plans).
• Coordinate with other functional groups for submission-related activities.
• Contribute strategic input to the design of data flow across EDC and non-EDC data sources within 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 in the biopharmaceutical industry; level determined by experience, technical proficiency, and people management
• Experience managing external data and 3rd party vendors
• Strong knowledge of regulations and guidelines governing clinical trials
• Excellent written and verbal communication skills and ability to work collaboratively as part of a team

Education

• Bachelor’s degree in science, math or computer science