Clinical Trial Manager

1‑Year Contract with potential for long term development | 30–40 Hours/Week | Remote (U.S.) – East Coast Preferred

We are seeking an experienced Clinical Trial Manager (CTM) to support a rapidly advancing Phase 3 gene therapy program. The ideal candidate will have extensive experience in clinical operations, site start‑up, CRO oversight, and cross‑functional coordination. This individual must be highly organized, persistent, and ready to drive urgency as the program transitions from Phase 1/2 into a pivotal Phase 3 cohort.

Responsibilities of the Clinical Trial Manager:

• Manage and oversee site start‑up activities for both existing and newly activated U.S. sites, with future expansion into global sites.
• Coordinate workflows for activation of 6 new sites while supporting the 4 active Phase 1/2 sites.
• Monitor and manage patient referral flow to ensure proper scheduling and site readiness.
• Drive timelines with the CRO (EMIS) and internal teams, addressing delays in NDAs, screening, and document execution.
• Implement and manage escalation plans when site or vendor responsiveness declines.
• Troubleshoot operational issues arising from recent Clinical Operations and CRO challenges.
• Work directly with the Chief Medical Officer (CMO) to remove barriers and accelerate progress.
• Collaborate cross‑functionally with Clinical Development, Regulatory, Finance, and other stakeholders.
• Support protocol amendments and ensure site teams understand updated requirements.
• Manage vendor performance and navigate potential communication or language barriers.
• Aid in database lock for Phase 2 and readiness for Cohort 6 (pivotal Phase 3 cohort) involving 53 patients.
• Prepare for future global site activations as the program scales.

Qualifications of the Clinical Trial Manager:

• Bachelor’s degree and 7–9 years of related experience;
• OR Master’s degree with 5–7 years of related experience;
• OR PhD in a scientific discipline with 3–5 years of related experience.
• Prefer experience in Clinical Trial Management at a biotech or pharmaceutical company.
• Experience with rare disease and/or ophthalmology trials preferred.
• Strong background in CRO and vendor management.
• Proven ability to handle multiple projects independently.
• Strong organizational skills, attention to detail, and excellent written/oral communication abilities.

Compensation for the Clinical Trial Manager:

• Pay Rate: $45-$55/hr
• Hours: 30–40 per week
• Location: Remote (U.S.), East Coast preferred
• Travel: Minimal
• Compensation: Competitive hourly rate, commensurate with experience
• Benefits: Health, Dental, Vision, and sick leave as required by law

Keywords: clinical trial manager, CTM, gene therapy, site start‑up, site activation, CRO oversight, vendor management, pivotal trial, rare disease, clinical operations, escalation management, protocol amendments, global site activation, ophthalmology, Phase 3

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Applications for this posting will be accepted for at least 30 days after the date posted (1/6).