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Job Description

Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Clinical Operations Manager in our Cambridge/Lexington office or 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 accomplish their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, 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. In close collaboration with Clinical Operations Program Lead(s)

• Oversee the development of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), and on budget.
• Oversee Strategic Partners, CROs, and other 3rd party vendors to meet Takeda's obligations described in ICH-GCP and Takeda's goals.

The assigned clinical studies may be of low to medium level of complexity. More than one study or more than one program may be assigned.

ACCOUNTABILITIES:

• Provide operational expertise and strategic input for assigned clinical trials.
• Provide 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.
• Validate budget and ensure impacts are adequately addressed.
• Participate in country and site feasibility/selection process, with a focus on providing country insights, corporate agreement and therapeutic expertise to ensure understanding 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 onboarded.
• During Early Engagement with Strategic Partner(s) or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and risk management plans are in place.
• Provide guidance to Strategic partners/CRO to ensure study issues are addressed and resolved.
• Oversee study budget planning and management and accountable for external spend related to study execution.
• Work with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure that budgets, enrollment, and gaiting are accurate; Communicate study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for vendors managed by Strategic Partner or other CROs.
• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper management 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:
• Approval of essential monitoring documents/plans, periodic review of outputs and actions related to monitoring
• Review and endorsement of relevant study plans, as applicable
• Study team meeting management and attendance; regular review of meeting agendas and minutes
• Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study
• Documented review and monitoring of risks and decisions at the study level and implementation of mitigation strategies
• In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between the strategy (i.e., filing/registration, data generation) 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 or attending the inspections.

EDUCATION AND EXPERIENCE:

• Bachelor's Degree (Life Science) or international equivalent required. Advanced degree(s) (i.e. Master or Doctorate) and training (i.e. fellowships, internships) may be considered to supplement experience requirements.
• 5+ years' experience in pharmaceutical industry or clinical research organization, including 3+ years clinical study management. 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 US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
• Experience in project management and matrix leadership.
• Fluent business English.

TRAVEL REQUIREMENTS:

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

WHAT TAKEDA CAN OFFER YOU:

• Base Salary Range: $120K-$140K. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

• The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.

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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.

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