Associate Director, Clinical Data Management — Phase 3 Lead

Generate:Biomedicines; Somerville (MA); On-site; USD 162,000 - 205,000; Full time

Job summary

Generate:Biomedicines is seeking an Associate Director of Clinical Data Management to lead data management for one or more clinical programs from start-up through database lock. The role emphasizes strategic leadership and hands-on execution in collaboration with cross-functional teams and CROs to ensure high-quality data.

The successful candidate will oversee study execution, vendor oversight, risk management, and data quality, serving as the primary data management representative for assigned

Qualifications

• Minimum 10+ years of clinical data management experience in pharma/biotech/CRO.
• Experience as lead data manager for Phase 2/3 trials.
• Strong data management knowledge: edit checks, reconciliation, data review.

Responsibilities

• Lead data management for phase 3 studies and programs.
• Oversee CRO/vendor data management activities and deliverables.
• Develop data management strategies, timelines, and governance.
• Ensure data quality, compliance with GCP and regulatory requirements.
• Manage data review, queries, reconciliation, and database lock.

Education

Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or related

Tools

Medidata Rave

Job description

Generate:Biomedicines is seeking an Associate Director of Clinical Data Management to lead data management for one or more clinical programs from start-up through database lock. The role emphasizes strategic leadership and hands-on execution in collaboration with cross-functional teams and CROs to ensure high-quality data.

The successful candidate will oversee study execution, vendor oversight, risk management, and data quality, serving as the primary data management representative for assigned