Clinical Trials Project Manager
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Job Description
Clinical Trials Project Manager managing clinical trials for Hawthorne Health. Ensuring compliance with regulations and optimizing study performance across multiple projects.
Responsibilities:
- 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, coordinating with internal teams (Regulatory, Contracts, Budget) to ensure efficient site activation.
- Serve as the primary operational liaison for Sponsors and CROs, providing regular updates on study progress, risks, and mitigation strategies.
- Develop and manage project plans, tracking milestones, timelines, enrollment targets, and overall study performance.
- Monitor site metrics including enrollment, data entry, and query resolution, implementing strategies to optimize study performance.
- Coordinate monitoring visits, audits, and investigator meetings, ensuring site readiness and proper study execution.
- 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:
- Bachelor’s degree in a scientific, healthcare, or related field.
- 3+ years of clinical research experience, including 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 (e.g., Medidata Rave, Oracle InForm) and eTMF.
- Excellent organizational and project management skills with the ability to manage multiple complex studies and timelines.
- Strong communication and stakeholder management skills, with the ability to convey complex information to site staff, sponsors, and internal teams.
- Demonstrated problem-solving and critical thinking abilities in a fast-paced research environment.
- PMP, CCRP, CCRA, or other project management/clinical research certifications are a plus.
Benefits:
- This remote role requires up to 30% travel
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