Manager Clinical Data
Monte Rosa Therapeutics, Inc
Overview The Manager, Data Management will be responsible for overseeing clinical data management activities across one or more clinical programs. This individual will work closely with Clinical Operations, Biostats and Programming, Medical, Safety, Regulatory, external CROs, and technology vendors to ensure high-quality, inspection-ready clinical data. This is a hands-on role well suited for someone who thrives in a small biotech environment, can manage external partners effectively, and is comfortable moving between strategy, execution, and problem-solving. 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.
- BS/MS degree in life sciences, data sciences, health sciences, or a related field.
- 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.
- Strong working knowledge of EDC systems such as Medidata Rave or similar platforms.
- Experience managing CROs and external clinical data vendors.
- Familiarity with clinical trial data standards, including CDISC, SDTM concepts, and database lock processes.
- Understanding of GCP, ICH guidelines, regulatory requirements, and clinical trial documentation standards.
- Strong attention to detail, organizational skills, and ability to manage multiple priorities in a fast-paced environment.
- Excellent communication and cross-functional collaboration skills.
- Experience in a small biotech or emerging pharmaceutical company.
- Experience with early-phase oncology trials, dose escalation, expansion cohorts, and complex biomarker-driven studies.
- Familiarity with molecularly targeted therapies, protein degradation, or immune-mediated disease programs.
- Experience with external data types such as genomics, biomarkers, PK/PD, central imaging, and specialty labs.
Vacancy posted 9 hours ago
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