Associate Director of Clinical Data Management

Role Summary

Associate Director of Clinical Data Management responsible for leading end-to-end Clinical Data Management activities on assigned studies and programs, managing 3rd party data sources, and serving as SME for Data Management within the Biometrics group. Collaborates with cross-functional teams in Clinical Development and Data Science. Manages CDM study activities, document reviews, CRO oversight, timelines, and project risk in a fast-paced environment.

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; proficiency in project management across 3‚Äì4 outsourced programs simultaneously.
• Represent Data Management in Clinical Study Meetings, aligning CRO and Recursion expectations for data-related deliverables.
• Collaborate with CRO and Recursion groups to complete EDC setup, database migrations/UAT, and systems such as IRT and ePRO; manage multiple vendor FTPs for data retrieval and delivery to statistical programming.
• Establish Vendor Oversight Plans for all studies; conduct Vendor Data Quality Reviews and Oversight; harmonize processes across Recursion clinical programs where relevant.
• Serve as SME for DM processes such as EDC, external data standardization, collection, and processing; lead efforts with Biometrics and Clinical Development for CRF data review plans; provide study metrics and propose data handling solutions.
• Lead/oversee creation and maintenance of Data Management documents (CDMP, CCGs, Data Review Plans, edit checks, listing reviews, data integration specs, data transfer specs, external data reconciliation plans, SAE reconciliation, coding guidelines, database lock, checklists, and plans).
• Coordinate with vendors to ensure data collection is compatible with clinical databases and meets SDTM requirements.
• Independently lead initiatives and collaborate cross-functionally; coordinate with other functions for submission-related activities.
• Manage input into design of data flow across EDC and non-EDC sources across vendor networks.
• Ensure filing, archival, and inspection readiness of all Data Management TMF activities.
• Review and manage external Data Management budgets; support budget planning and forecasting.
• Support development of Clinical Data Management SOPs and Work Instructions.
• Comply with GCPs, regulatory guidelines, SOPs, policies, and CDM guidance documents.

Qualifications

• Bachelor‚Äôs degree in science, math, or computer science
• 12+ years‚Äô experience 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 collaborate effectively as part of a team

Skills

• Clinical Data Management systems (EDC, IRT, ePRO)
• Vendor management and outsourcing oversight
• Data standardization and SDTM compliance
• Data review planning, edit checks, data integration specifications
• Project management and cross-functional collaboration

Education

• Bachelor‚Äôs degree in science, math, or computer science

Additional Requirements

• Working location: Salt Lake City or New York City; hybrid environment requiring 50% in-office time
• Relocation support available