GMA, GME Operations, Study Implementation Lead, EUCAN

at  Takeda Pharmaceutical

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

JOB DESCRIPTION

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.
Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

ACCOUNTABILITIES

• Support the preparation of study synopsis and study protocol of EUCAN RWE studies in different Therapeutic Areas with the support of the relevant Evidence Generation Lead and Medical Lead
• Prepare RFPs, detailed timelines and budget and establish a contract / SOW with selected CRO
• Support/manage initial submissions and manage study start-up, activation, implementation, execution, study close-out and reporting activities, including overseeing study related documentation and plans (e.g. Study Management Plan, Risk Assessment Plan, etc.)
• Participate in Steering Committee Meetings and provide regular updates on study progress
• Maintain and oversee the TMF and relevant study repositories until study closure / reporting
• Support LOC study implementation and study execution in accordance with Takeda policies and procedures

KEY CAPABILITIES

• Knowledge in outcomes, Real-World Evidence studies and Epidemiologic research
• Project Management experience with a proven track record in study start-up and execution
• In-depth knowledge of GCP, GVP and GPP
• Advanced knowledge of the pharmaceutical industry, including experience with data generation within life-cycle development and knowledge of clinical studies and associated documents and systems
• Extensive knowledge of regulations and industry standards applicable to RWE studies
• Vendor management experience
• Experience managing study management systems and study document repositories

EDUCATION, BEHAVIORAL COMPETENCES AND SKILLS

• Minimum MSc degree (preferably PhD), preferably in a health sciences related field with 8 years of research related experience and/or pharmaceutical industry experience (including CRO)
• Strong written and verbal communication skills (English)

• Accountable for overseeing EUCAN RWE Medical Affairs Company Sponsored (MACS) study preparation in different Therapeutic Areas for both in line and pipeline products with the support of the relevant Evidence Generation Lead and Medical Lead/Head
• Accountable for supporting internal submissions, Feasibility Assessments and study activations of EUCAN RWE MACS studies
• Accountable for overseeing EUCAN RWE Study Execution and study plans (including Study Management Plan and Risk Assessment Plan)
• Responsible for engaging with external vendors/CROs at selection/contracting and for overseeing vendors/CRO activities through the end of the study
• Responsible for maintaining and overseeing the TMF until study close-out and reporting
• Responsible for the conduct of studies in accordance with all applicable internal legal and compliance policies (SOPs) as well as applicable regional or country specific regulatory guidelines