Clinical Trials Project Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $100k - $120k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

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Hawthorne Health

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2000

🏥 Healthcare

🎯 Recruiter

Healthcare • Recruitment

Hawthorne Health is a recruitment agency specializing in sourcing healthcare professionals, particularly in nursing and allied health. The company provides healthcare employment solutions, serving both clients and candidates with a commitment to quality, integrity, and affordability. Operating with a team of experienced health recruitment specialists, Hawthorne Health offers personalized services and flexible staffing solutions tailored to meet HR needs. They recruit talent from Australia and internationally, ensuring a high level of service for those seeking work and those requiring healthcare staffing.

📋 Description

• 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

• 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

• Remote work arrangement • Up to 30% travel