Clinical Data Manager
Monte Rosa Therapeutics
July 01, 2026
Remote friendly (Boston, MA)
United States
$115,000 - $135,000 USD yearly
Clinical Research and Development
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 (lab, PK, biomarker, imaging, safety, IRT).
- 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/timelines, performance oversight, and issue escalation.
- Contribute to process development and continuous improvement as operations scale.
Qualifications:
- BS/MS in life sciences, data sciences, health sciences, or related field.
- 8+ years clinical data management experience in biotech/pharma/CRO.
- Experience in oncology and/or immune disease trials.
- Strong working knowledge of EDC systems (e.g., Medidata Rave).
- Experience managing CROs and external clinical data vendors.
- Familiarity with CDISC, SDTM, and database lock processes.
- Understanding of GCP, ICH, regulatory requirements, and clinical trial documentation.
- Strong attention to detail; able to manage multiple priorities; excellent communication/collaboration.
- Experience in a small biotech/emerging pharmaceutical company.
- Experience with early-phase oncology (dose escalation, expansion cohorts, complex biomarker studies) and molecularly targeted/protein degradation/immune-mediated programs.
- Experience with external data types (genomics, biomarkers, PK/PD, central imaging, specialty labs).
Application Instructions:
- Apply online with CV and cover letter in one document via the career portal.
- 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 (lab, PK, biomarker, imaging, safety, IRT).
- 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/timelines, performance oversight, and issue escalation.
- Contribute to process development and continuous improvement as operations scale.
Qualifications:
- BS/MS in life sciences, data sciences, health sciences, or related field.
- 8+ years clinical data management experience in biotech/pharma/CRO.
- Experience in oncology and/or immune disease trials.
- Strong working knowledge of EDC systems (e.g., Medidata Rave).
- Experience managing CROs and external clinical data vendors.
- Familiarity with CDISC, SDTM, and database lock processes.
- Understanding of GCP, ICH, regulatory requirements, and clinical trial documentation.
- Strong attention to detail; able to manage multiple priorities; excellent communication/collaboration.
- Experience in a small biotech/emerging pharmaceutical company.
- Experience with early-phase oncology (dose escalation, expansion cohorts, complex biomarker studies) and molecularly targeted/protein degradation/immune-mediated programs.
- Experience with external data types (genomics, biomarkers, PK/PD, central imaging, specialty labs).
Application Instructions:
- Apply online with CV and cover letter in one document via the career portal.