Senior Clinical Data Manager – Oncology Trials

Monte Rosa Therapeutics; Boston (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

Monte Rosa Therapeutics, a clinical-stage biotech, is seeking a Manager, Data Management to oversee data management across trials. You will collaborate with Clinical Operations, Biostats, Programming, Medical, Safety, Regulatory, CROs, and vendors to ensure inspection-ready data.

This hands-on role requires experience with EDC systems (Medidata Rave or similar), data standards (CDISC/SDTM), and strong project leadership in oncology-focused studies.

Qualifications

• 8+ years of clinical data management experience in biotech, pharmaceutical, CRO, or related clinical research settings.
• Experience supporting oncology and/or immune disease clinical trials.
• Experience managing CROs and external clinical data vendors.
• Understanding of GCP, ICH guidelines, regulatory requirements, and clinical trial documentation standards.

Responsibilities

• Oversee end-to-end clinical data management activities for assigned studies, from study start-up through database lock.
• Manage CROs, EDC vendors, central labs, imaging vendors, eCOA providers, IRT vendors, and other data providers.
• Review and contribute to key study documents, including data management plans, edit check specifications, CRF completion guidelines, data transfer agreements, and data review plans.
• Support CRF design, database build, user acceptance testing, and EDC system validation activities.
• Ensure timely data cleaning, query management, reconciliation, coding, and database lock activities.
• Coordinate external data transfers and reconciliations, including laboratory, pharmacokinetic, biomarker, imaging, safety, and IRT data.
• Partner with Clinical Operations and study teams to identify data quality issues and drive resolution.
• Support medical coding activities using MedDRA and WHODrug, as applicable.
• Contribute to clinical data review meetings and help prepare data outputs for internal decision-making.
• Maintain data management documentation in compliance with GCP, ICH guidelines, SOPs, and regulatory expectations.
• Support vendor selection, budget review, timelines, performance oversight, and issue escalation.
• Contribute to process development and continuous improvement as the company scales its clinical operations infrastructure.

Skills

Attention to detail

Organizational skills

Communication

Cross-functional collaboration

Problem-solving

Education

BS/MS degree in life sciences

Tools

Medidata Rave

CDISC SDTM

Job description

Monte Rosa Therapeutics, a clinical-stage biotech, is seeking a Manager, Data Management to oversee data management across trials. You will collaborate with Clinical Operations, Biostats, Programming, Medical, Safety, Regulatory, CROs, and vendors to ensure inspection-ready data.

This hands-on role requires experience with EDC systems (Medidata Rave or similar), data standards (CDISC/SDTM), and strong project leadership in oncology-focused studies.