Senior Global Trial Manager – Single Sponsor
Are you experienced in managing late phase clinical trials at a global level? Join our Single Sponsor Department and take ownership of delivering late‑phase clinical trials that meet timelines, budgets, and quality standards. As a core Clinical Trial Team member, you'll lead critical aspects of global studies and collaborate across functions to drive success.
As part of your role, you’ll have the opportunity to specialize in one of the following areas:
* Scientific Review Committee (SRC)
* Non‑Interventional Studies (NIS)
* Managed Access Programs (MAP)
* Investigator‑Initiated Trials (IITs)
* Research Collaborations (RCs)
* Program Level Documents (PLD)
Key Responsibilities
Clinical Documentation & Study Tools
* Draft sections of protocols, CRFs, training materials, and data review plans
* Contribute to the development of safety updates, IBs, and regulatory submissions
Project Leadership
* Oversee data review and TMF audit readiness
* Forecast/manage investigational product supply
* Support study closeout, issue resolution, and lifecycle budget tracking
* Contribute to Managed Access Program coordination and compliance
Vendor & Stakeholder Management
* Coordinate CRO/vendor selection and performance
* Facilitate advisory boards (DMCs/Steering Committees) and serve as the site liaison
* Lead cross‑functional collaboration with data management, drug supply, and more
What You’ll Bring
* Advanced degree in life sciences or healthcare
* 2–5 years' global experience managing phase IV, PASS, PAES, or NIS trials
* Strong track record in protocol development, study startup, and regulatory writing (e.g. PSURs, DSURs, NDA/BLA reports)
* Excellent communication, organizational, and collaboration skills
* Deep understanding of GCP and clinical trial design
* Passion for advancing real‑world evidence and patient outcomes
Please note this role is not eligible for the UK visa sponsorship.
Please note: due to sponsor requirements for the role only candidates based in the listed location(s) will be considered. Any applications from candidates based outside of these locations will not be considered.
#J-18808-Ljbffr