Associate Director, Clinical Data Standards
Company: Takeda Pharmaceutical
Location: Cambridge
Posted on: April 17, 2024
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Job Description:
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Job Description
About the role:
At Takeda, we are a forward-looking, world-class R&D
organization that unlocks innovation and delivers transformative
therapies to patients. By focusing R&D efforts on four
therapeutic areas and other targeted investments, we push the
boundaries of what is possible in order to bring life-changing
therapies to patients worldwide.
Join Takeda as an Associate Director, Clinical Data Standards where
you will be responsible for driving the strategy for Takeda's
global data standards, processes, and technologies across the
clinical data continuum for quality of deliverables and global data
interoperability. You will also actively participate in and
influences Data Standards forums (internally or externally) to
maintain awareness of any initiatives and trends that could be
incorporated into or enhance Takeda's Therapeutic Area Clinical
Data Standards Library. As part of the Data Standards team, you
will report to the head of clinical data standards and work with
groups across the data science team.
How you will contribute:
Provides input to clinical data standards governance with Takeda's
strategic stakeholders.
Partners with appropriate stakeholders to resolve issues escalated
from the vendor and/or cross-functional teams.
Participates and represents function in formal inspections and
audits as requested.
Maintains SOPs, process maps and templates and timelines to support
functions operational and oversight models.
Represents function in external professional initiatives and
organizations such as CDISC, PhUSE, SCDM, SCOPE, PharmaSUG,
TransCelerate, Accumulus, DIA, etc. to identify industry best
practice and increase the visibility of Takeda.
Partners with internal stakeholders, clinical operations, CDM, and
external CROs and provide guidance on data harmonization across
diverse sources.
Leads process and workflow improvement in areas of Standards
implementation from Sample Collection through Data Transfer.
Defines and/or Leads functional Continuous Improvement initiatives,
providing strategic direction and identifying key deliverables that
meet timelines, budget, and are in alignment with company,
departmental or functional requirements.
Ensures compliance with own Learning Curricula, corporate and/or
GXP requirements.
Works cross-functionally to ensure the quality of the data in each
database and on time delivery, as well as quality of other data
deliverables.
Contributes to the development of strategies and governance for
assessing, implementing, and integrating systems and tools to
support, manage, govern and report on data standards.
Responsible for the maintenance of structure and content of
Takeda's MDR - Metadata Repository in one or more of the areas:
data transfer specifications, eCRF and other data collection
methods e.g., eSource, ePRO, forms, controlled terminologies,
instructions, edit checks, SDTM mappings, ADaM and TLF standard
libraries.
Leads and enforces maintenance and decommissioning of Clinical Data
Standards models (including but not limited to: CDASH, SDTM,
Controlled Terminology, ADaM, TLFs and questionnaires). Includes
regular assessment of standards content with respect to compliance
and industry impacts. May prepare metrics to support the function's
KPIs.
Minimum Requirements/Qualifications:
BS/BA or MS in a life science or analytical area with minimum 10
years of experience in a CRO/pharmaceutical environment with a
proven and consistent record of proactive management and
innovation.
Previous experience leading a medium to large organization and
influencing senior-level management and key stakeholders is a
plus.
Proven track record of leading and driving business process
transformation and organizational culture change as well as
delivering on programs with complex business deliverables.
More about us:
At Takeda, we are transforming patient care through the development
of novel specialty pharmaceuticals and best in class patient
support programs. Takeda is a patient-focused company that will
inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating
careers, encourages innovation, and strives for excellence in
everything we do. We foster an inclusive, collaborative workplace,
in which our teams are united by an unwavering commitment to
deliver Better Health and a Brighter Future to people around the
world.
This position is currently classified as "remote" in accordance
with Takeda's Hybrid and Remote Work policy.
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:
Cambridge, MAU.S. Base Salary Range:
$149,100.00 - $234,300.00The 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
Cambridge, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time--s-p-m1--
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Keywords: Takeda Pharmaceutical, Brookline , Associate Director, Clinical Data Standards, Executive , Cambridge, Massachusetts
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