Lead Clinical Study Manager

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 Job Description Job Title: Lead Clinical Study Manager ( Lead CSM) BU/Organization: Global Development Organization (GDO) Department/ Function: Global Clinical Development Operations (GCDO) / Study Management Location and Flex Work Arrangement: Remote Job Code / Job Profile : not required for contractor 6009926 3 Supervisor: Associate Director/Director, Study Management Compensation Grade Profile: not required for contractor 150 Objective / Purpose : Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan . In close collaboration with Clinical Operations Program Lead(s): Lead the cross functional study execution team (SET) for assigned clinical studies program (s) to meet study objectives in compliance with quality standards ( including ICH GCP, local regulations and Takeda SOPs ), on schedule and on budget. Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives . M ay collaborate with one, or more, CSMs, or other study management colleagues The assigned clinical studies may be of high- level of complexity and/or high priority . More than one study and/or more than one program may be assigned Accountabilities : Acco untable for planning and operational strategy and execution for assigned clinical trials. Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents. Challenges study execution team (SET) to ensure operational feasibility, inclusive of patient and site burden Validates budget and ensures impacts are adequately addressed. Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy. Challenges study execution team (SET) to ensure timelines meet the needs of the clinical development plan. Ensure new team members and vendors