Lead Clinical Study Manager

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 

60099263  

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.  

• May 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:  

• Accountable 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 are appropriately onboarded.  

• During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.  

• Provide oversight/support/guidance to Strategic partners/CRO to ensure study risks are identified and mitigated, and issues are addressed and resolved rapidly.   

• Responsible for study budget planning and management and accountable for external spend related to end-to-end study execution.  Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, external spend, enrollment, and ensure timely updates of budget and financial systems are accurate. Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Takeda and/or Strategic Partner and/or other CROs.  

• Communicates study status, cost and issues to Clinical Operations Program Lead(s); serves as escalation point for third party vendors managed by Takeda, Strategic Partner and/or other CROs.  

• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.   

• Specific areas of sponsor oversight include, but are not limited to:  

• Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring  

•  Review and endorsement of relevant study plans, as applicable  

• Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study  

• Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies   

• In partnership with data management, statistics and regulatory teams to review and provide input on all database timelines and plans, ensuring strong alignment between study data generation, database lock (DBL), and clinical study report (CSR) delivery; in accordance with overarching filing and registration strategies. 

• Ensure studies are “inspection ready” at all time; in the case of a regulatory agency inspection the Lead CSM will be involved in preparing for and/or attending the inspection as a subject matter expert on the conduct of the trial.   

• Represent the Clinical Study Manager role in functional initiatives or working groups.    

• Help with onboarding and mentoring of study management teams members. 

• May assist the program COPL in his/her role, as required. 

Education & Competencies (Technical and Behavioral):  

• BS/BA required, preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience  

• 6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight.  Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs.  Experience in more than one therapeutic area is advantageous.  

• Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.  

• Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTR, and ICH GCP.  Awareness of local country requirements is also required.  

• Demonstrated successful experience in project/program management and matrix leadership 

• Good communication skills  

• Excellent teamwork, organizational, interpersonal, and problem-solving skills  

• Fluent business English (oral and written) 

• Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.