Senior Clinical Operations Manager
Company: Takeda Pharmaceutical
Posted on: May 12, 2022
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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 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
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
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 assigned.
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 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.
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 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 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 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 and attending the
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 EXPERIENCE:
Bachelor's Degree (Life Sciences) or international equivalent.
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 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.
excellence in project management and matrix leadership.
Fluent business English.
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
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs
Location and Salary Information:
Base Salary Range: $140K-$160K based on candidate professional
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 Shine
Learn more at takedajobs.com .
No Phone Calls or Recruiters Please.
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.
Massachusetts - Virtual
Keywords: Takeda Pharmaceutical, Clifton , Senior Clinical Operations Manager, Accounting, Auditing , Clifton, New Jersey
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