Clinical Trials Project Manager

Hawthorne Health is a leading community site network and home research visit solution provider. The Clinical Trials Project Manager is responsible for the day-to-day operations of assigned clinical trials, ensuring successful execution in accordance with program goals, timelines, budgets, and quality expectations.

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
• 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
• Experience working with a clinical research network, CRO, or pharmaceutical/biotech sponsor strongly preferred
• PMP, CCRP, CCRA, or other project management/clinical research certifications are a plus