[Hiring] Lead Clinical Study Manager @Takeda

Role Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. We offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

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.
• 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.
• The assigned clinical studies may be high complexity and/or high risk, requiring the coordination of multiple vendors, or other special assessments.

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, focusing on providing country insights, corporate alignment and therapeutic expertise.
• Challenges study team to ensure timelines meet the needs of the clinical development plan.
• Ensure new team members and vendors are appropriately onboarded.
• Lead the development of the Operational Strategy in preparation for Operational Strategy Review.
• 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.
• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance.
• Specific areas of sponsor oversight include review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring.
• Ensure studies are “inspection ready” at all times; may be involved in regulatory 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.

Qualifications

• 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.
• Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
• 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).

Requirements

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

Benefits

• We understand compensation is an important factor as you consider the next step in your career.
• We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
• U.S. Base Salary Range: $116,000.00 - $182,270.00.
• The actual base salary offered may depend on various factors, including qualifications, years of relevant experience, specific skills, level of education attained, certifications, and location.