Lead Clinical Study Manager

Goals

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)

• 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 Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.

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 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.
• Ensures 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.
• Provides oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.
• Oversees 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.

Education and Experience

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

Travel Requirements

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

Takeda Compensation and Benefits Summary

• U.S. based employees may be eligible for short-term and/ or long-term incentives.
• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.