Senior Clinical Operations Manager
Company: Takeda Pharmaceutical
Posted on: May 15, 2022
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
that all information I submit in my employment application is true
to the best of my knowledge.
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 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 assigned.
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.
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 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 and attending the inspections.
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 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. excellence in
project management and matrix leadership. Fluent business
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 Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
screenings Generous time off for vacation and the option to
purchase additional vacation days Community Outreach Programs
Location 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 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, Yonkers , Senior Clinical Operations Manager, Healthcare , Closter, New York
Didn't find what you're looking for? Search again!