Full-Time Clinical Project Manager (Remote)

Role OverviewThe Clinical Project Manager is a team-player role supporting clinical operations for our programs. This individual possesses clinical operations expertise and a track record of success, collaborating with peers and stakeholders across disciplines to drive a key program through all phases of clinical trials (Phase I-III). The Clinical Project Manager works closely with vendors and clinical sites.

Responsibilities

• Prepare/review site feasibility reports and support study team in site selection.
• Ensure efficient study start-up by overseeing CROs and vendors and working with relevant team members (CMC, Reg, etc). Ensure timeline collection of all start-up documents, site Clinical Trial Agreements and start-up activities are performed prior to site activation.
• Assist Director of Clinical Operations in reviewing study timelines and milestones.
• Review site visits, conduct study oversights as needed and support oversight of vendors (CRO, lab vendors, etc).
• Assist in preparing and implementing study plans (Monitoring Plan, Oversight Plan, etc).
• Collaborate with Clinical Development, Regulatory Affairs, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives.
• Serve as point of contact for CROs and vendors, overseeing their performance, adherence to agreements, timelines, and quality standards.
• Ensure compliance with regulatory requirements (ICH-GCP) and company SOPs.
• Oversee data collection, analysis, and interpretation, working with Clinical Development, Biostatistics, and Data Management teams for accuracy and integrity.
• Contribute to preparation and review of clinical study documents (Investigator Brochure, IND, protocols, reports, NDA/MAA sections, IND updates, safety reports).
• Forge strong relationships with investigators, site staff, and CROs, overseeing operational strategies to achieve program goals.
• Oversee timely capture, reporting, and evaluation of adverse events and product safety issues.
• Oversee clinical and regulatory files, including the Trial Master File (TMF).
• Manage clinical trials from start-up to close-out ensuring on-time/on-budget deliverables, collaborating across functional areas.
• Proactively manage outsourced partners, identifying risks to ensure trial deliverables and performance goals are met.
• Maintain partnerships through positive relationships with CRO counterparts, proactively reviewing sites for potential issues and communicating/escalating to leadership.
• Collaborate with CROs to keep the clinical study database current, accurate, and cleaned.
• Support and manage oversight activities of all necessary vendors to ensure operational excellence.

Qualifications

• BA/BS in health-related field preferred; MA/MS in biological/life sciences, nursing or related field is a plus.
• 5+ years of clinical operations experience in pharmaceutical/biotechnology.
• Strong experience in managing and developing relationships with CROs.
• Demonstrated excellence in managing clinical trials and understanding of trial processes.
• Proven track record of success, innovative program/trial execution to ensure study progress, timelines, data integrity, and compliance.
• Domain expertise in drug development, early-stage clinical trials preferred.
• Strong vendor and project management skills.
• Ability to manage multiple priorities and adapt to changes.
• Global studies (multiple countries/sites) experience required.
• Pediatric trials/rare disease experience a plus.
• Strong working knowledge of GCP/ICH and other applicable regulations.

Travel Requirements

Remote role requiring up to 25% travel.

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