GMA Evidence Generation Operations Manager
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
What makes a successful member of our team?
We take action and make decisions by focusing on our four priorities in this order:
Putting the patient
at the center
Life at Takeda
To keep delivering new value to patients, we provide growth opportunities for every employee according to their abilities and passions, and together are building a stronger organization.
Procurement Lead, Northern Europe
“Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”
Regional Head, Europe, Vaccines
“Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
GMA Evidence Generation Operations ManagerApply Now
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.
Job ID R0012058