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Clinical Trials Project Manager
Hawthorne Health. Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance .
Tech Stack
Tools & technologiesOraclePMP
About the role
Key responsibilities & impact- Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance
- Assess protocol feasibility and support study planning, including resource allocation, budget considerations, and recruitment strategy development
- Drive study start-up timelines and coordinate with Regulatory, Contracts, and Budget teams for site activation
- Serve as the primary operational liaison for Sponsors and CROs, providing updates on study progress, risks, and mitigation strategies
- Develop and manage project plans, tracking milestones, timelines, enrollment targets, and study performance
- Monitor site metrics including enrollment, data entry, and query resolution, implementing study-performance optimization strategies
- Coordinate monitoring visits, audits, and investigator meetings
- Support regulatory and compliance activities, including essential document collection, IRB submissions, protocol amendments, and safety reporting
- Act as a central resource for site teams, resolving operational and protocol-related challenges and driving timely solutions
Requirements
What you’ll need- Bachelor’s degree in a scientific, healthcare, or related field preferred
- 3+ years of clinical research experience
- At least 2 years in a Project Manager, Clinical Trial Manager (CTM), or Lead CRC role
- Experience working with a clinical research network, CRO, or pharmaceutical/biotech sponsor strongly preferred
- Strong knowledge of ICH-GCP guidelines and regulatory requirements governing clinical trials
- Proficiency with clinical trial systems, including EDC platforms such as Medidata Rave and Oracle InForm, and eTMF
- Excellent organizational and project management skills
- Strong communication and stakeholder management skills
- Demonstrated problem-solving and critical thinking abilities
- PMP, CCRP, CCRA, or other project management/clinical research certifications are a plus
Benefits
Comp & perks- Remote work arrangement
- Up to 30% travel