Piper Companies · 1 day ago
Clinical Trial Manager
Piper Companies is seeking an experienced Clinical Trial Manager to support a rapidly advancing Phase 3 gene therapy program. The role involves managing site start-up activities, coordinating workflows, and collaborating with various stakeholders to ensure the program's success.
Responsibilities
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
Qualification
Required
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
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
Preferred
Prefer experience in Clinical Trial Management at a biotech or pharmaceutical company
Experience with rare disease and/or ophthalmology trials preferred
Benefits
Health
Dental
Vision
Sick leave as required by law
Company
Piper Companies
At Piper, we obsess about the success of our customers and consultants.
H1B Sponsorship
Piper Companies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (1)
2023 (2)
2022 (2)
2021 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase