Associate Director, Clinical Data Standards

Company: Takeda Pharmaceutical
Location: Cambridge
Posted on: April 17, 2024

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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