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Senior Manager, GCP Excellence in Clinical Trials

Remote
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  • Job Level: Senior
  • Travel: Minimal (if any)

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

Job ID R0143715 Date posted 02/25/2025 Location Remote

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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Manager, GCP Excellence in Clinical Trials based remotely reporting to the Associate Director, GCP Excellence in Clinical Trials.

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. Certified as a Global Top Employer, 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:

  • Project manage and facilitate cross-functional study execution teams’ GCP inspection readiness and inspection activities, including strategies to support process adherence, well-maintained TMF documentation and proactive study team preparedness for audits and inspections.
  • Manage cross-functionally to assure aligned approach to inspection readiness strategy with Clinical Quality Assurance (CQA) and Global Development Compliance partners is actioned to study execution teams.
  • Champion inspection readiness process improvements and provide direct change management support for clinical trial delivery projects and initiatives.
  • Coordinate and manage TMF process and inspection readiness strategies in collaboration with study execution teams and GCP Excellence in Clinical Trials leadership.

ACCOUNTABILITIES:

  • Provide project management, oversight, and expert GCP guidance to study execution teams in Inspection Readiness including, but not limited to, Inspection Readiness Plans, completion of Inspection Readiness Checklist, TMF quality and process adherence, identification & mitigation of inspection risks, storyboard development for high-risk issues, and creation of functional presentations in preparation for mock and actual inspection.
  • Manage study execution teams in prioritizing process adherence, inspection readiness deliverables and mitigation of inspection risks throughout the study lifecycle.
  • Lead and guide study teams on adherence to ways of working and associated documentation and deliverables.
  • Collaborate cross-functionally and manage/action compliance monitoring signals with study execution teams.  Provide reporting to senior leadership on key performance indicators and mitigation strategies related to clinical trial inspection readiness including quality TMF documentation.
  • Identify and engage appropriate Sponsor and CRO SMEs in the inspection readiness activities.  Actively participate in Strategy Team Meetings and Lead Core Team Meetings for assigned Inspection Readiness projects.
  • Maintain documentation such as project management plans/trackers, timelines, and progress reports to track, manage, and report on study execution teams’ inspection readiness.
  • During inspections, manage functional teams by facilitating request strategies and responses with appropriate functional SMEs; providing necessary follow-up and guidance to ensure timely fulfillment; liaising with functional SMEs and QA to assure alignment; providing regular status updates to appropriate stakeholders and leadership.
  • Contribute to development of and lead assigned departmental objectives, representing GCP Excellence globally. Develop and implement GCP Excellence processes to enhance support and compliance, identifying areas for improvement.
  • Manage study-execution teams in development of risk-based TMF oversight strategies.  Monitor compliance of TMF deliverables and oversight of resources in the execution of inspection readiness plans.
  • May serve as TMF subject matter expert for regulatory inspections of Takeda, responsible for ensuring execution of IR strategy and assist with presentation/representation of TMF Process to inspectorate.
  • May participate in management of day to day activities of assigned staff providing guidance, coaching and supporting issue escalation to achieve organizational and individual development goals.

EDUCATION AND EXPERIENCE:

  • Bachelor’s degree preferred or commensurate with experience.
  • 6 or more years clinical research experience in pharmaceutical or biotechnology field required.
  • Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required.
  • Knowledge of and experience in regulatory inspection readiness and execution processes.
  • Experience with CROs and outsourced clinical trial activities.
  • Solid knowledge of drug development and clinical trial processes, including related standards and documents.
  • Solid knowledge of regulatory requirements governing clinical trials and industry best practices.
  • Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations.

Takeda Compensation and Benefits Summary

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.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$137,000.00 - $215,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. 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.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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During my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.

Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations

When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.

Meredith Culp - VP, Head of Neuroscience Therapeutic Area Strategy & Operations and Head of Global Development Integration Office

Our culture and shared values make us like a family here at Takeda. It doesn't feel like work when you're doing something you love with people you love, and when your outcome is really fantastic.

Alison Handley, Head, Center for External Innovation

The heart of our work

Shining a light on new perspectives

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.