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iHire · 5 days ago

Lead Clinical Study Manager

Boston, MA

Full-time

Hybrid

Mid, Senior Level

$112K/yr - $176K/yr

6+ years exp

Takeda Pharmaceutical, in partnership with iHire, is seeking a Lead Clinical Study Manager to contribute to their mission of transforming the pharmaceutical industry. This role involves leading the operational strategy and planning for clinical studies, ensuring compliance with quality standards, and managing relationships with strategic partners and CROs.

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Comp. & Benefits

Responsibilities

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

Oversee the execution of studies in assigned clinical program(s) 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 Takedas obligations described in ICH-GCP and Takedas business objectives

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 team 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 team 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 issues are addressed and resolved rapidly

Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by 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; Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes; 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, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR

Ensure studies are inspection ready at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections

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

Help with onboarding and mentoring of new or junior CSMs

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

Qualification

Clinical study managementRegulatory complianceBudget managementProject managementFluent business EnglishTeamworkCommunication skillsProblem-solving skillsOrganizational skills

Required

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

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

Demonstrated excellence in project/program management and matrix leadership

Excellent communication skills

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

Fluent business English (oral and written)

Preferred

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

Experience in more than one therapeutic area is advantageous