Senior Clinical Data Manager - Data Integrity & CRO Oversight

Relay Therapeutics; Cambridge (MA); On-site; USD 129,000 - 184,000; Full time

Job summary

Relay Therapeutics seeks a Sr Manager, Clinical Data Management to oversee data management activities across clinical studies, ensuring data quality, integrity, and timely delivery. You will lead CRO oversight, database development, eCRF design, and data cleaning through to database lock in a fast-paced, collaborative setting.

Your background includes 7+ years in pharma/biotech/CRO as a Data Manager, with preference for Oncology and experience in Medidata Rave, EDC integrations, and advanced

Qualifications

• 7+ years of experience in the pharmaceutical/biotechnology and/or CRO industry as a Data Manager.
• Data cleaning experience in Oncology studies is preferred.
• Sponsor experience is preferred.
• Experience with Medidata Rave and EDC integration with external vendor systems.

Responsibilities

• Oversee and execute data management activities for assigned studies, including timelines and key deliverables.
• Oversee CROs and vendors for outsourced data management activities and monitor performance and metrics.
• Lead database development, eCRF design, UAT, data import specs, CRF completion guidelines, data entry guidelines and related manuals.
• Lead data validation specifications to ensure trial data accuracy (edit checks, DMPs).
• Execute or oversee data cleaning through to database lock, including queries, listings, coding and reconciliation of SAEs and central labs.
• Provide technical and business expertise to support data management activities and study teams.
• Collaborate with study team members and oversee CRO data cleaning and database lock activities.
• Review and maintain completeness QCs of study eTMF for Data Management documentation.
• Oversee RAVE user access QCs and ensure compliance with regulatory standards.

Skills

Data management expertise

Project coordination

Communication & public speaking

Interpersonal skills

Tools

Medidata Rave

EDC integration

MS Excel advanced

Job description

Relay Therapeutics seeks a Sr Manager, Clinical Data Management to oversee data management activities across clinical studies, ensuring data quality, integrity, and timely delivery. You will lead CRO oversight, database development, eCRF design, and data cleaning through to database lock in a fast-paced, collaborative setting.

Your background includes 7+ years in pharma/biotech/CRO as a Data Manager, with preference for Oncology and experience in Medidata Rave, EDC integrations, and advanced