Associate Director of Clinical Data Management

Role Summary

Recursion seeks an Associate Director, Clinical Data Management to lead end-to-end CDM activities on assigned studies and programs, manage 3rd party data sources, and act as a SME for Data Management within Biometrics. You will collaborate with cross-functional groups within Clinical Development and Data Science, overseeing study activities, documentation, CRO oversight, timelines, and risk management in a fast-paced environment.

Responsibilities

• Lead End to End Data Management activities with hands-on management of outsourced studies and lead DM and external vendor oversight activities and deliverables. Proficiency in project management leading 3-4 outsourced programs, simultaneously.
• Represent Data Management in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion 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, ePRO, etc. Manage multiple vendor SFTPs for data retrieval and delivery to statistical programming.
• Establish Vendor Oversight Plans for all studies and be responsible for Vendor Data Quality Reviews and Oversight, harmonizing processes where relevant with other Recursion clinical programs.
• Serve as a SME for operational activities and DM processes like EDC, external data standardization, collection, and processing; lead efforts for creation and standardization of CRFs and Data Review Plans; routinely provide study metrics, deliverable planning, and 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 vendors to ensure data collection is compatible with clinical databases and meets SDTM requirements.
• Strategic and critical thinker who can independently lead initiatives and collaborate cross-functionally.
• Coordinate with other functional groups for submission-related activities.
• Manage strategic input into the design of data flow across EDC and non-EDC data sources across vendor networks.
• Ensure filing, archival, and inspection readiness of all Data Management Trial Master File (TMF) activities.
• Review and manage external Data Management budgets, ensure accuracy, and understand trends to support budget planning and forecasting.
• Support the development of Clinical Data Management Standard Operating Procedures and Work Instructions.
• Comply with GCPs, regulatory guidelines, SOPs, policies, and CDM guidance documents.

Qualifications

• Required: Bachelor’s degree in science, math or computer science.
• Required: 12+ years’ experience in the biopharmaceutical industry. Experience, technical proficiency, and people management skills will determine the level.
• Required: Experience managing external data and 3rd party vendors.
• Required: Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
• Required: 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