Clinical Trials Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the execution of clinical trials across the site network, managing study initiation, activation, and ongoing operational performance.

• Evaluate protocol feasibility and assist in study planning, which includes resource allocation, budget considerations, and the development of recruitment strategies.

• Propel study initiation timelines and collaborate with Regulatory, Contracts, and Budget teams for site activation.

• Act as the primary operational liaison for Sponsors and CROs, offering updates on study progress, risks, and strategies for mitigation.

• Create and manage project plans, monitoring milestones, timelines, enrollment targets, and overall study performance.

• Track site metrics such as enrollment, data entry, and query resolution, applying strategies to optimize study performance.

• Organize monitoring visits, audits, and investigator meetings.

• Assist with regulatory and compliance activities, including the collection of essential documents, IRB submissions, protocol amendments, and safety reporting.

• Serve as a central resource for site teams, addressing operational and protocol-related challenges and facilitating timely solutions.

⛳️ Requirements

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

• A minimum of 3 years of experience in clinical research.

• At least 2 years in roles such as Project Manager, Clinical Trial Manager (CTM), or Lead CRC.

• Experience with a clinical research network, CRO, or pharmaceutical/biotech sponsor is highly preferred.

• In-depth knowledge of ICH-GCP guidelines and regulatory requirements governing clinical trials.

• Proficient in clinical trial systems, including EDC platforms like Medidata Rave and Oracle InForm, as well as eTMF.

• Exceptional organizational and project management skills.

• Strong communication and stakeholder management capabilities.

• Proven problem-solving and critical thinking skills.

• Certifications such as PMP, CCRP, CCRA, or other project management/clinical research credentials are advantageous.

🏝️ Benefits

• Flexible remote work options.

• Travel requirements of up to 30%.