Regional Clinical Trial Manager
New
Located in the US, global time zonesFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 7-10 years clinical research experience
- Required Skills
- GCPBudget management
Requirements
- Bachelor’s degree in a science or life science discipline; advanced degree preferred.
- Minimum 7-10 years of clinical research experience as a CRA or equivalent.
- At least 3 years of clinical project management or operations management experience.
- Demonstrated clinical monitoring and/or data management experience.
- Recent experience leading global phase 3 studies from start to completion.
- Experience in rare disease clinical trials (ALS or Huntington’s Disease preferred).
- Expert understanding of FDA guidelines, GCP, ICH, and SOPs.
- Demonstrated budget management experience.
- Proven ability to manage CROs and hold them accountable to KPIs.
- Proficiency with EDC, eTMF, IWRS, CTMS, and Microsoft Office.
- Ability to travel up to 50% domestically and internationally.
Responsibilities
- Oversee and manage regional operational activities for global pivotal trials in neurodegeneration.
- Supervise multi-study regional operations across Phase I-III and conduct ad-hoc site visits.
- Develop and oversee procedures for troubleshooting and problem-solving.
- Establish and monitor programs, protocols, and site procedures.
- Evaluate the suitability of site personnel and facilities for trial conduct.
- Maintain effective communication with vendors and internal departments.
- Build and sustain cross-functional relationships within global teams.
- Communicate progress, risks, and strategic insights to executive leadership.
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