Category: Scientific & Clinical
Title: Global Study Leader
Location: Princeton, NJ
- Lead and manage a cross-clinical delivery sub team to operationally deliver defined clinical studies or clinical project activities to time, cost and appropriate quality.
- Lead the operational delivery of clinical studies, via a team of contributing experts from the study specification to the final clinical study report and archived master file.
- Provide input into study feasibility and study specifications, and produce essential documents including the authoring of clinical study protocols across both interventional and non-interventional studies.
- When working across studies or project work package ensures consistency across the development program.
- To be the interface to partners and oversee the delivery to plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic
- Research Organizations) and to monitor progress, identify and solve operational issues.
- Lead/contribute to clinical submission assembly, regulatory response and payer evidence teams and contributes to advisory board and steering committee meetings.
- Management of changes to project scope and costs (including CRO and other vendors change orders) and reporting project status by participating in project planning and control activities and generation of status reports as required.
- Accountable for agreeing with the project team and functions the most efficient procedures to support delivery by taking the project situation and compliance requirements into account.
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
- At least 10 years’ experience from within the pharmaceutical industry or similar organization or academic experience.
- Extensive knowledge of clinical operations, project management and processes
- Good experience of clinical development / drug development process in various phases of development and therapy areas.
- Project management certification is desirable but not mandatory.
- Evidence of developing partnering skills
- Ability to learn and Passion to develop team members
International Travel Involved!