Lead Clinical Study Manager

Job Description

Job Title:

LeadClinical Study Manager (LeadCSM)

BU/Organization:

Global DevelopmentOrganization(GDO)

Department/
Function:

Global ClinicalDevelopment Operations (GCDO) /

Study Management

Location and Flex Work Arrangement:

Remote

Job Code/
JobProfile:
notrequiredfor contractor

60099263

Supervisor:

Associate Director/Director, Study Management

Compensation Grade Profile:
notrequiredfor 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 crossfunctionalstudyexecutionteam (SET) forassignedclinical studiesprogram(s) tomeetstudyobjectivesin compliance withqualitystandards (includingICH GCP,localregulationsandTakedaSOPs), on schedule and on budget.

• OverseeStrategic Partners and/orotherCROsandother3rd partyvendorstomeetTakeda’sobligationsdescribedin ICH-GCP andTakeda’sbusinessobjectives. 

• May collaborate with one, or more, CSMs, or other study management colleagues

• Theassignedclinical studiesmaybe of high-levelofcomplexityand/or highpriority. Morethanone study and/or morethanoneprogrammaybeassigned

Accountabilities:

• Accountable for planning and operational strategy and executionforassigned clinical trials. 

• Provides subject matterexpertiseand operational input into protocol synopsis, finalprotocoland other study related documents. 

• Challengesstudyexecutionteam(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 onprovidingcountry insights, corporatealignmentand therapeuticexpertiseto ensure alignment between study execution plan and program strategy. 

• Challengesstudyexecutionteam(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 ensuringaccurateassumptions are applied and robust risk management plans are in place. 

• Provide oversight/support/guidance to Strategic partners/CRO to ensure studyrisks areidentifiedand mitigated, andissues are addressed and resolved rapidly.  

• Responsible for study budget planning and management and accountable for externalspendrelated toend-to-endstudy execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets,externalspend,enrollment, andensuretimelyupdates of budget and financialsystemsareaccurate.Communicates study status,costand issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed byTakedaand/orStrategic Partner and/or other CROs. 

• Communicates study status,costand issues toClinical Operations Program Lead(s); servesas escalation point for third party vendors managed byTakeda,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 reviewis 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 ofappropriate mitigationstrategies 

• In partnership with data management,statisticsandregulatoryteamstoreview and provide input onalldatabase timelines and plans,ensuringstrongalignmentbetweenstudy data generation, database lock (DBL), and clinical study report (CSR) delivery;inaccordancewithoverarchingfilingandregistrationstrategies.

• Ensure studies are “inspection ready” at alltime;in the case of a regulatory agency inspection the Lead CSM willbe involved inpreparing for and/or attending the inspectionas a subject matter expert on the conduct of the trial.  

• Represent theClinicalStudy Managerrole in functional initiatives or working groups.  

• Help with onboarding and mentoring ofstudy managementteamsmembers.

• MayassisttheprogramCOPL in his/her role, asrequired.

Education & Competencies(Technical and Behavioral): 

• BS/BArequired, preferably in a health-related, life science area or technology-related fields or equivalent combination of education,trainingand experience 

• 6+years’experienceinpharmaceuticalindustryand/or clinicalresearchorganization,including4+yearsclinical study management/oversight.  Experience must includeeitherearlyphaseclinical studies orPhase2 and 3 studies and global/international studies orprograms.  Experience in morethanonetherapeuticareaisadvantageous. 

• Advanced degree(s) (e.g., Master orDoctorate) andrelevanttraining orexperience(e.g., fellowship. internships, etc.)maybeconsideredtosupplementexperiencerequirements. 

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

• Demonstratedsuccessfulexperiencein project/programmanagement andmatrixleadership

• Goodcommunicationskills 

• Excellentteamwork,organizational,interpersonal, andproblem-solving skills 

• Fluent business English (oralandwritten)

• Requiresapproximately5-20 % travel,includingovernight and international travel tootherTakedasites,strategicpartners, andtherapeuticarearequiredtravel.