■This is what you will do:
Evidence Generation Lead manages all evidence generation program such as the Externally Sponsored Research (ESR), Medical Affairs conducting Phase 4 (P4) study Real-world evidence generation, HEOR study and Post marketing surveillance (PMS) etc. through providing operational supports such as facilitating contract, selecting and managing CRO/vender, evaluating FMV, monitoring progress and milestone, challenging new and innovative approaches, and collaborating with other business functionsincluding legal/compliance.  Evidence Generation Lead oversees processes, systems and activities related to evidence generation program from a variety of internal and external sources to ensure data is centrally maintained, managed and available for various stakeholders to access seamlessly in real-time.

■You will be responsible for:

Manage all evidence generation projects conducted by Japan Medical Affairs, including, but not limited to, ESRs, P4 studies, Database research, PMS in all phases through providing operational and technical supports to medical affairs business owner:

Before initiation: educate MA staffs on internal and external process, compliance, regulation, basics of life-science research, facilitating TARC, facilitating communication with global counterparts, evaluating feasibility and timeline

At initiation of study: facilitate contact, helping milestone design, selection of CRO/vender, determining FMV, helping investigators to manage CRO/ARO

During study: Monitor project status and budget, and provide regular report on progress, risks, and recommendations for course corrections if necessary. Monitor milestones and receive outcomes timely as a project manager. Track and facilitate publications

End of study: make sure the studies are appropriately and compliantly closed following relevant SOPs in terms of operation, patient safety, milestones and deliverables, contract and payments including pass through

Throughout study: Manage day to day study/research operational aspects to ensure Business Continuity across cross functional groups such Legal, Compliance, Finance, Medical and Business Leads.

Liaise Japan MA TA members who is responsible for successful project progress

Liaise with internal support functions (e.g. Legal, Purchasing, Compliance, Quality, Accounts Payable) , global support functions (ESR manager) and external vendors to ensure processes are followed.

Support and maintain the overall study budget (study invoice, Purchase Order PO tracking)

Ensure transparency over areas of budget responsibility by updating through relevant systems Manage and reconcile Contracts, POs, invoices and Amendments

Lead and resolve outstanding Invoice/PO issues and communicate in a timely manner to the study sponsor.