Hawthorne Health - Clinical Trials Project Manager
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT
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.
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.
Similar Jobs
No credit card. Takes 10 seconds.