Full-Time Senior Clinical Project Manager

Senior Clinical Project Manager/Clinical Project Manager (Remote)

About the Role:

The Senior Clinical Project Manager/Clinical Project Manager supports clinical operations for programs. This role requires clinical operations expertise and a proven track record, collaboration with peers and stakeholders across disciplines, to drive programs through all phases of clinical trials (Phase I-III).

Responsibilities:

• Prepare/review site feasibility reports, supporting site selection.
• Ensure efficient study start-up, overseeing CROs, vendors, and relevant teams (CMC, Reg).
• Collect start-up documents, site agreements, and complete start-up activities before site activation.
• Review study timelines and milestones with Director of Clinical Operations.
• Manage scope, changes, contracts, site agreements, and budgetary information.
• Conduct site visits and study oversights as needed.
• Oversee vendor performance (CROs, labs).
• Assist in study plan preparation/implementation (Monitoring Plan, Oversight Plan).
• Collaborate with internal teams (Clinical Development, Regulatory, Translational Medicine, Leadership).
• Serve as point-of-contact for CROs, ensuring compliance and quality.
• Ensure compliance with regulatory requirements (ICH-GCP, company SOPs).
• Oversee clinical trial data collection, analysis, and interpretation with Clinical Development, Biostatistics, and Data Management.
• Prepare/review clinical study documents (Investigator Brochure, INDs, protocols, reports).
• Develop strong relationships with investigators, site staff, and CROs, overseeing operational strategies.
• Oversee adverse event capture, reporting, and evaluation.
• Manage clinical and regulatory files (TMF).
• Support timely information and material exchange for clinical trial deliverables.
• Manage trials from start-up through close-out, ensuring internal/external deliverables are on time and on budget.
• Manage outsourced partners, identifying risks, and ensuring trial goals are met.
• Maintain partnerships with CRO counterparts, proactively resolving issues.
• Keep clinical study database current, accurate, and cleaned.
• Support and manage vendor oversight for operational excellence.

Qualifications:

• BA/BS in health-related field (preferred), or MA/MS in related field.
• 5+ years experience in clinical operations.
• Strong CRO management experience.
• Demonstrated clinical trial management excellence and trial process understanding.
• Proven success in program/trial execution, ensuring study progress and compliance.
• Drug development domain expertise (early-stage trial experience preferred).
• Strong vendor and project management skills.
• Multi-tasking and adaptability skills.
• Excellent communication, interpersonal, and problem-solving abilities.
• Fast-paced environment comfort level.
• Global studies experience (multiple countries/sites).
• Pediatric/rare disease experience (an asset).
• Teamwork and cross-functional collaboration.
• Strong GCP/ICH knowledge.
• Strong written and verbal English.
• Travel required (domestic/international).

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