Senior Clinical Trial Manager, Research Alliances
New
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Iovance BiotherapeuticsBiotechnology
RemoteFull-TimeSenior
Salary165,000 - 185,000 USD per year
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Job Details
- Experience
- 7+ (Sr. CTM) or 5+ (CTM) years
Requirements
- Bachelor’s degree in a health or science-related area.
- 7+ years (for Senior level) or 5+ years of clinical operations experience in pharmaceutical or biotech.
- Demonstrated ability to independently initiate and manage Expanded Access Programs and Phase 1–4 clinical trials.
- In-depth knowledge of ICH-GCP, FDA-CFR, and Sunshine Act compliance.
- Proficiency with EDC systems (e.g., eClinical, Medidata RAVE, InForm) and electronic Trial Master File systems.
- Proven track record of building and maintaining effective relationships with investigative sites.
- Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Ability to travel 15% of the time.
- Experience in oncology or immunotherapy is preferred.
- Experience with Phase 4 and Expanded Access Programs is preferred.
Responsibilities
- Oversee activation and management of Expanded Access Programs (EAPs) at treatment centers.
- Lead activities for Post Marketing studies.
- Manage Investigator Sponsored Trials (ISTs) and non-clinical research collaborations.
- Coordinate with Legal for CDAs, clinical trial agreements, and contract amendments.
- Supervise external contract research organizations (CROs) regarding site monitoring and data management.
- Ensure Sunshine Act reporting data collection for lifileucel and Proleukin products.
- Develop and maintain dashboards to communicate study status, progress, and risks.
- Write and update workflows, manuals, and technical documents for clinical programs.
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