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Hawthorne Health

Clinical Trials Project Manager (copy)

Posted 4 days ago
United States
$100K - $120K per year
2-5 years experience
oracle clinical-research project-management operations critical-thinking compliance
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AI Summary

The Clinical Trials Project Manager oversees the day-to-day operations of assigned clinical trials, ensuring they are executed according to company goals, timelines, and regulatory standards. They serve as the primary liaison for sponsors and CROs while managing site performance, study start-up, and regulatory compliance.

About Us 

Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. Hawthorne leverages convenient, trusted, healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs. By embedding high-quality research within local communities, Hawthorne makes clinical trials more accessible and convenient for patients. Our community-based model shortens timelines and helps bring better treatments to market, faster. 

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About the Role
The Clinical Trials Project Manager is an integral piece of Hawthorne Health’s business and is critical to achieving success in delivering a high-quality experience for our clients, Health Research Outcomes Professionals (HEROs), and the larger patient population. This individual is responsible for the day-to-day operations of assigned clinical trials/programs (“projects”) as well as serving as a cross-functional leader to ensure projects are executed successfully and in accordance with the company’s overall program goals, timeline, budget and quality expectations and are in compliance with the company’s procedures, FDA regulations, GCP, ICH requirements and any other applicable regulations. The ideal person to fit this role is highly organized, collaborative, communicates well, and has progressive clinical trial oversight experience.


Key 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.


Qualifications
  • Bachelor’s degree in a scientific, healthcare, or related field preferred.
  • 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.

     


Additional Information
  • This remote role requires up to 30% travel


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$100,000 - $120,000 a year

Final rate determined based on experience and qualifications.

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Hawthorne Health is transforming the clinical trial landscape through an innovative site model that integrates research into community-based settings like local pharmacies. By meeting patients where they already receive care, we are improving access, strengthening trust, and driving more inclusive and efficient trials.

We welcome the opportunity to connect with individuals interested in being part of this evolving model.

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