Senior Clinical Operations Manager
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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knowledge.Job DescriptionAre 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 Senior
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 a 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 operational
strategy 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), you will:
- 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 high complexity and high
risk, e.g. multiple indications, data safety monitoring boards and
endpoint review committees, interim analyses, requiring the
coordination of multiple vendors, or other special assessments.
More than one study or more than one program may be
- Provide operational expertise and strategic input for assigned
- 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
- 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.
- Challenge study team to ensure timelines meet the needs of the
clinical development plan.
- Ensure new team members and vendors are onboarded.
- 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
- 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 guidance of performance for all
activities assigned to a strategic partner/CRO/vendor for assigned
studies, including escalation of issues to governance committees
- 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
- 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 and attending
- Represent the Senior Clinical Operations Manager role in
functional projects or working groups.
- Help with onboarding and mentoring of new or junior COMs.
- May assist the program COPL in your role.EDUCATION AND
- Bachelor's Degree (Life Sciences) or international
- 6+ years' experience in pharmaceutical industry or clinical
research organization, including 4+ years clinical study
- Experience must include either early phase clinical studies or
Phase 2 and 3 studies and global/international studies or
- Experience in more than one therapeutic area is
- 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.
- excellence 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:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsLocation and Salary Information:
- Location(s): Remote
- Base Salary Range: $140K-$160K based on candidate professional
experience level.This posting is made in compliance with Colorado's
Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.Empower Our
People to ShineLearn more at .No Phone Calls or Recruiters
Please.EEO StatementTakeda 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Paterson , Senior Clinical Operations Manager, Healthcare , Paramus, New Jersey
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