GMA Evidence Generation Operations Manager応募 後で応募 求人ID R0012058 掲載日 09/17/2019 Location:Zurich, Switzerland
GMA EVIDENCE GENERATION OPERATIONS MANAGER
(Global External Research)
- Manage all aspects of assigned program including Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR), and Externally Sponsored Collaborative Clinical Research (CCR) studies for assigned therapeutic areas and product programs.
- Manage TA and product level study budgets and communicate study activities to internal stakeholders.
- Oversee and manage the activities of EGO project managers, including the initiation, tracking, completion, and reporting of studies.
- Responsible for the conduct of studies in accordance with all applicable internal legal and compliance policies (SOPs) as well as external regional and country specific regulatory guidelines.
- May serve as the therapeutic operational area lead for interfacing with internal stakeholders (e.g. GMA, Region and LOC medical leads, TA Medical Heads, alliance partners, etc.) and external investigators to develop and execute research plans and budgets.
- Oversee and/or facilitate receipt, processing, and internal cross-functional review of internal/external study submissions
- Review and approve research committee materials including study concepts and protocols, meeting minutes, and investigator communications.
- Lead required cross-functional review meetings to review, approve, and track studies and ensure proper documentation and archiving (minutes, team communications, etc.) of review outcomes.
- Coordinate the capture, archiving and reporting of appropriate study level information (including patient safety information).
- Oversee and/or facilitate the management of the internal EGO VisionTracker (or equivalent system) and document repositories per Medical Affairs SOPs and processes.
- Coordinate with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies.
- Contribute to pre- fair market value (FMV) evaluation of proposed study budget and oversee the conduct of FMV assessments of budgets submitted for approved studies in accordance with Takeda policies and procedures.
- Bachelor’s degree required, preferably in a health sciences related field with 3 years of research related experience and/or pharmaceutical industry experience.
- Proven track record of strong leadership, project management and demonstrated ability to coach and mentor individuals.
- Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of clients both internal and external to Takeda.
- Experience overseeing work of and mentoring other individuals with a variety of scientific and non-scientific backgrounds and training
- Research experience (health sciences related), Pharmaceutical Industry including CRO
- Experience working in a global organization highly desirable.