Clinical Operations Manager
$164,000–$199,000 year
On-siteSomerville, Massachusetts, United States
Job Summary
Lead the cross-functional study team to manage global clinical trials from start-up to close-out, overseeing budget, timelines, and vendor performance for CROs and third-party providers. Develop and present operational strategy, author study protocols and regulatory documents, and lead feasibility assessments for region and country selection. Conduct ongoing risk identification, ensure inspection readiness, and manage site selection, recruitment, and retention strategies. Monitor clinical trial data, metrics, and compliance with ICH/GCP guidelines while escalating issues to stakeholders to maintain study deliverables.
Required Qualifications
- Bachelor's degree in a relevant scientific or healthcare discipline
- 8+ years of clinical operations experience
- 4+ years as a clinical trial manager
- Experience in managing global clinical operations for first-in-human to Phase 3 Programs from start-up to close out
- Experience managing clinical CRO and other vendors
- Experience managing budgets and timelines
- In depth knowledge of ICH/GCP guidelines
- Working knowledge of regulatory guidelines/directives
- Proficiency in trial management systems, IVRS/IWRS, eTMF, EDC, SmartSheets and Microsoft applications including Project, PowerPoint, Word and Excel
- FDA and other regulatory inspection experience
- Current rare disease experience and/or gene therapy experience
- Effective project management skills
- Cross-functional team leadership
- Organizational skills
- Ability to thrive in a fast-paced environment
- Demonstrated ability to prioritize and manage multiple competing tasks
- Flexibility to adapt to changing program needs
- Excellent team management abilities
- Ability to partner with and proactively manage internal stakeholders, CROs, and vendors
- Ability to collaborate cross-functionally to deliver global clinical trials according to the planned timelines and budget
- Ensuring quality in accordance with ICH-GCP guidelines and regulatory requirements
Desired Qualifications
- Experience managing global clinical operations for first-in-human to Phase 3 Programs from start-up to close out, including managing clinical CRO and other vendors, budgets and timelines
- FDA and other regulatory inspection experience is a plus
- Current rare disease experience and/or gene therapy experience is highly preferred
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