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.
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.

Benefits

This remote role requires up to 30% travel

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial executionprotocol feasibility assessmentresource allocationbudget considerationsstudy planningproject managementenrollment trackingdata entryquery resolutionregulatory compliance

Soft Skills

organizational skillsproject management skillscommunication skillsstakeholder managementproblem-solvingcritical thinking

Certifications

PMPCCRPCCRA