Prime Medicine
Associate Director, Clinical Data Management
Watertown, MA · Director · Full-time
Sponsorship not specified$174k-$193kDetected 8 hours ago
GCPData VisualizationStatisticsProject ManagementProcess ImprovementPerformance ManagementICD-10Clinical TrialsFDA RegulatoryCRISPRLeadershipCommunicationCollaboration
About the role
- Oversee external data transfers and reconciliation processes (e.g., SAE, lab, PK and PD).
- Contribute to scalable data infrastructure and identification of key efficiencies between programs
Responsibilities
- Lead all clinical data management activities across multiple programs from IND through BLA submission.
- Develop and execute data management strategies aligned with regulatory requirements both in the US/ex-US
- Oversee CRF design, database build, edit checks, data review, coding, reconciliation, and database lock.
- Ensure implementation of CDISC standards (SDTM/ADaM) to support submission readiness.
- Support inspection readiness and maintain audit-ready documentation.
- Lead selection, oversight, and performance management of CRO and data management vendors.
- Manage vendor budgets, timelines, KPIs, and quality metrics.
Requirements
- 8+ years of progressive clinical data management experience, including leadership responsibility.
- Experience supporting IND submissions and major regulatory filings (BLA/NDA/MAA).
- Demonstrated CRO/vendor oversight experience in global trials.
- Strong knowledge of ICH/GCP, FDA/CFR regulations, CDISC standards, and eCTD submission requirements.
- Strong understanding of safety data reconciliation and regulatory inspection preparedness.
- Experience with EDC systems, medical coding (MedDRA/WHO Drug), and external data integration.
- Key Competencies
- Strategic thinker with strong execution skills.
- Detail-oriented with high standards for data quality and compliance.
- Collaborative and cross-functional mindset.
- Comfortable working in a dynamic, innovative biotech environment.
Nice to have
- Bachelor's degree in life sciences, statistics, informatics, or related field (advanced degree preferred).
- Direct experience in rare disease and/or gene therapy, gene editing, or advanced biologics strongly preferred.
Skills
- Ensure change control, database archiving, and data governance processes are compliant and well documented.
- Excellent organizational, project management, and communication skills.
Compensation
- $174,000 - $193,000 USD
Equal opportunity
- Prime Medicine is proud to be an equal opportunity employer.
Apply directly at Prime Medicine →Create a free account for alerts like thisView Prime Medicine immigration profile
This listing is sourced directly from Prime Medicine's careers page and normalized into a canonical job model.