Clinical Project Manager
Relay Therapeutics
June 29, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Plan, implement, and execute global clinical trial(s) from startup through closeout; integrate project team activities and optimize CRO resources.
- Partner with cross-functional teams to deliver studies on time and within budget while ensuring protocol and ICH GCP quality.
- Lead global patient recruitment planning (including assumptions documentation).
- Build and maintain relationships with internal/external stakeholders (cross-functional teams, CROs, external experts, clinical sites) to ensure timely, cost-effective service delivery.
- Provide progress reports and key metrics to senior management and program teams.
- Contribute to/author study documents (protocols, informed consent forms, case report forms, governance charters such as DMCs, study plans, clinical study reports).
- Accountable for vendor management (primary CRO/vendor contact; identify risks and resolve issues; ensure contracts and KPIs; manage budgeting and cost accruals).
- Ensure data quality via review of monitoring reports, protocol deviations, clinical data listings, and site monitoring visits.
- Develop timelines/enrollment projections; contribute to KPIs and risk mitigation strategies.
- Monitor and manage vendor/site performance and trial progress/quality; drive corrective/preventive actions.
- Lead coordination with CROs for site selection, IRB/EC submissions, queries, initiation, and close-out.
- Oversee maintenance of clinical trial master files (TMF) to meet regulatory/ICH GCP standards and SOPs.
- Plan and lead study-specific meetings; support regulatory filings (e.g., IND/NDA/orphan drug applications) as needed.
- Ensure inspection readiness with CROs and support sites for audits/inspections.
- Share best practices, recommend continuous improvements, and train/mentor as appropriate; support recruitment and professional development.
Qualifications:
- 5–8 years clinical research experience; 1–2 years managing trials in biotech/pharma; BA/BS (scientific/health-related preferred).
- Global Phase I–III trial/study team experience (startup–closeout); strong GCP/ICH and applicable regulations knowledge; preference for late-phase biotech/pharma experience.
- Experience with global study startup, site startup processes/timelines; multiple therapeutic areas (oncology a plus).
- Drug development and clinical trial process knowledge; understanding of budgets/accruals/forecasting (liaise with Finance).
- Ability to lead in fast-paced matrix environments; prioritize multiple tasks.
- Relationship-building with CROs, KOLs, and sites; willingness to travel.
- Vendor selection and CRO-managed study oversight experience.
- Strong interpersonal, problem-solving, judgment, and communication/organizational skills.
Estimated salary range: $102,000–$145,000.
- Plan, implement, and execute global clinical trial(s) from startup through closeout; integrate project team activities and optimize CRO resources.
- Partner with cross-functional teams to deliver studies on time and within budget while ensuring protocol and ICH GCP quality.
- Lead global patient recruitment planning (including assumptions documentation).
- Build and maintain relationships with internal/external stakeholders (cross-functional teams, CROs, external experts, clinical sites) to ensure timely, cost-effective service delivery.
- Provide progress reports and key metrics to senior management and program teams.
- Contribute to/author study documents (protocols, informed consent forms, case report forms, governance charters such as DMCs, study plans, clinical study reports).
- Accountable for vendor management (primary CRO/vendor contact; identify risks and resolve issues; ensure contracts and KPIs; manage budgeting and cost accruals).
- Ensure data quality via review of monitoring reports, protocol deviations, clinical data listings, and site monitoring visits.
- Develop timelines/enrollment projections; contribute to KPIs and risk mitigation strategies.
- Monitor and manage vendor/site performance and trial progress/quality; drive corrective/preventive actions.
- Lead coordination with CROs for site selection, IRB/EC submissions, queries, initiation, and close-out.
- Oversee maintenance of clinical trial master files (TMF) to meet regulatory/ICH GCP standards and SOPs.
- Plan and lead study-specific meetings; support regulatory filings (e.g., IND/NDA/orphan drug applications) as needed.
- Ensure inspection readiness with CROs and support sites for audits/inspections.
- Share best practices, recommend continuous improvements, and train/mentor as appropriate; support recruitment and professional development.
Qualifications:
- 5–8 years clinical research experience; 1–2 years managing trials in biotech/pharma; BA/BS (scientific/health-related preferred).
- Global Phase I–III trial/study team experience (startup–closeout); strong GCP/ICH and applicable regulations knowledge; preference for late-phase biotech/pharma experience.
- Experience with global study startup, site startup processes/timelines; multiple therapeutic areas (oncology a plus).
- Drug development and clinical trial process knowledge; understanding of budgets/accruals/forecasting (liaise with Finance).
- Ability to lead in fast-paced matrix environments; prioritize multiple tasks.
- Relationship-building with CROs, KOLs, and sites; willingness to travel.
- Vendor selection and CRO-managed study oversight experience.
- Strong interpersonal, problem-solving, judgment, and communication/organizational skills.
Estimated salary range: $102,000–$145,000.