Job Details

Position Summary
The Senior Clinical Data Manager will lead clinical data management activities for sponsored clinical trials from trial start-up through database lock, archival, and regulatory submission support. This individual will provide hands-on data management expertise and sponsor oversight of CROs and third-party vendors, partnering closely with Clinical Operations, Clinical Development, Safety, Regulatory, Translational Medicine, and external vendors to ensure timely, accurate, complete, and inspection-ready clinical trial data in accordance with GCP, ICH guidelines, applicable regulatory requirements, data privacy requirements, and SOPs.

The ideal candidate brings deep CDM expertise, sound judgment in identifying and escalating data quality risks, and the ability to translate protocol requirements into practical data collection and review strategies. This is a role for someone who operates with high ownership and follow-through, thrives in a lean, fast-moving biotech environment, and is deeply committed to patient safety, data integrity, and regulatory-quality trial execution.

The successful candidate will also value a highly collaborative, in-person team culture and be expected to work on-site in our Cambridge office three or more days per week.

Key Responsibilities
Trial Leadership & Data Management

• Develop and maintain key data management documents, including the Data Management Plan, eCRF specifications, completion guidelines, edit check specifications, data validation plan, data transfer specifications, external data reconciliation plans, medical coding plan, and database lock plan.
• Establish and track data management timelines, deliverables, milestones, risks, and mitigation plans; provide regular updates to management.

• Oversee and provide hands-on review of Medidata Rave eCRF design, database build, edit checks, testing, UAT, go-live, change control, and database lock activities, including approval of database change requests during study conduct.
• Ensure eCRF design and database structure support protocol requirements, efficient data cleaning, SDTM mapping, and regulatory submission readiness; apply CDASH principles and maintain alignment with CDISC standards (SDTM, ADaM).
• Oversee data cleaning and lead cross-functional data review — including adverse events, serious adverse events, concomitant medications, laboratory data, exposure, dose modifications, tumor assessments, and protocol deviations — to ensure data are accurate, complete, traceable, and available in support of safety surveillance, regulatory reporting, and clinical decision-making.

External Data, Vendor Oversight & Compliance

• Serve as primary point of contact and provide sponsor oversight of CRO data management activities and third-party vendors (IRT, central and local laboratory, imaging, safety, PK/PD, biomarker, genomic, and specialty testing), ensuring deliverables meet quality expectations and align with protocol requirements, data standards, regulatory expectations, and study timelines.
• Monitor CRO and vendor performance metrics (query aging, data cleaning, external data transfers, reconciliation, coding, database lock readiness) and escalate data quality, timeline, or vendor performance issues as needed.
• Oversee medical coding (MedDRA, WHODrug) and risk-based data quality review through listings, dashboards, metrics, trend analyses, and issue escalation.
• Ensure data management activities comply with GCP, ICH guidelines, FDA and global regulatory requirements, GDPR, HIPAA, and SOPs; champion data integrity, traceability, and inspection readiness across all data management deliverables.

• Maintain Trial Master File documentation; support audits, inspections, and regulatory submissions; and lead or participate in process improvement initiatives that enhance data quality, efficiency, and scalability across clinical trials.

Qualifications

• Bachelor’s degree in life sciences, health sciences, computer science, data science, or a related field.
• Minimum of 7 years of clinical data management experience in industry-sponsored clinical trials, with significant hands-on study lead experience from study start-up through database lock.
• Experience providing sponsor oversight of CROs and third-party vendors, including external data transfer specifications, reconciliation, and data cleaning metrics.
• Hands-on experience with Medidata Rave, including eCRF design review, edit check review, UAT, query management, data exports, user access review, and database change control.
• Strong understanding of clinical data management practices, GCP, ICH guidelines, FDA requirements, and related global regulatory expectations.
• Working knowledge of CDISC standards (CDASH, SDTM, ADaM) and how database design supports downstream SDTM mapping and regulatory submission readiness.
• Experience with MedDRA and WHODrug coding oversight.
• Strong project management skills, with the ability to manage timelines, deliverables, risks, issues, and cross-functional communication.
• Experience supporting oncology trials, including RECIST-based tumor assessments, prior therapies, PK/PD, immunogenicity, biomarkers, and central imaging data preferred.