Associate Director of Clinical Data Management

Role Summary

Associate Director of Clinical Data Management responsible for leading end-to-end CDM activities on assigned studies and programs, managing 3rd party data sources, and serving as the SME for Data Management within the Biometrics group. You will lead and deliver CDM initiatives, collaborate across Clinical Development and Data Science teams, and oversee study activities, deliverables, and vendor oversight. Location: Salt Lake City, UT or New York City, NY; hybrid work environment requiring 50% in the office.

Responsibilities

• Lead end-to-end data management activities, manage outsourced studies, and oversee DM and external vendor deliverables; proficient in managing 3-4 outsourced programs concurrently.
• Represent Data Management in Clinical Study Meetings to align CRO expectations with Recursion on data-related deliverables.
• Collaborate with CRO and Recursion functional groups to complete EDC setup, database migrations/UAT, and systems such as IRT and ePRO; manage multiple vendor FTPs for data retrieval and delivery.
• Establish Vendor Oversight Plans; perform Vendor Data Quality Reviews and Oversight; harmonize processes across programs where relevant.
• Act as SME for DM processes (EDC, external data standardization, collection, processing); lead creation and standardization of CRFs, Data Review Plans, and related deliverables; provide study metrics and issue-resolution solutions.
• Lead the creation and maintenance of DM documents (CDMP, CCGs, Data Review Plans, edit checks, listings, 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 thinker who can independently lead initiatives and collaborate cross-functionally; coordinate with other functional groups for submission-related activities.
• Manage data flow design across EDC and non-EDC data sources across vendor networks; ensure TMF filing, archival, and inspection readiness.
• Review and manage external Data Management Budgets; support budget planning and forecasting.
• Support development of Clinical Data Management SOPs and Work Instructions; ensure compliance with GCPs, regulatory guidelines, SOPs, policies, and CDM guidance documents.

Qualifications

• Bachelor’s degree in science, math, or computer science.
• 12+ years of experience in the biopharmaceutical industry; level determined by experience, technical proficiency, and people management skills.
• Experience managing external data and 3rd party vendors is essential.
• 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.

Education

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