Associate Director, Clinical Data Standards
Company: Takeda Pharmaceutical
Location: Cresskill
Posted on: May 9, 2022
Job Description:
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
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionTakeda fosters a collaborative and
stimulating work environment, filled with opportunity and the
chance to make a difference in people's lives. It is a workplace
driven by integrity, one of Takeda's long-held values that extends
to both the patients we serve and our employees who develop and
deliver medicines. Across our company, Takeda employees bring
together diverse strengths that together create a stronger whole.As
one of the world's leading biopharmaceutical companies, Takeda is
committed to bringing Better Health and a Brighter future to people
worldwide. We aspire to bring our leadership in translating science
into life-changing medicines to the next level, in our core focus
areas; gastroenterology, oncology, neuroscience, plasma-derived
therapies, rare diseases and vaccines. Boston (Massachusetts) is
the R&D headquarters.Statistical & Quantitative Sciences (SQS)
at TakedaKey to Takeda's success is the Statistical & Quantitative
Sciences Team (SQS), providing Strategic planning, resourcing, and
oversight of clinical trial data deliverables.SQS engages in
strategic partnerships, overseeing expert CROs to ensure successful
execution and delivery of Clinical Data. SQS also owns Takeda's
strategy for the development and governance of Data Standards, in
alignment with the CDISC (Clinical Data Interchange Standards
Consortium) industry standards. SQS performs oversight and in-house
activities pertaining to standards and study data. SQS is
responsible for Data Collection (e.g., EDC, IVR, ePRO, eCOA), Data
Tabulation, Data Analysis and Reporting technologies and other
related tools and/or applications.Associate Director, Clinical Data
StandardsThe Associate Director, Clinical Data Standards is
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. They are Takeda's Data Standards Leaders and
SMEs, actively participating in and influencing 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. -The
Associate Director, Clinical Data Standards supports enforcement of
Takeda's Global Data Standards Governance to ensure proper
utilization of standards, adherence to standards processes, and the
timely, thorough assessment of library enhancements and deviations.
They are leading the identification, review/evaluation, deployment
and usage of technologies to generate, distribute, and/or integrate
with and report on standards compliance internally, manages
in-house programs along with standards vendor(s) to support
Standards Management vision.The Associate Director, Clinical Data
Standards builds relationships across the global Takeda
organization and with CROs/strategic service providers, provides
project management leadership of standards projects and have the
ability to partner closely with internal/external standards
stakeholders, and serves as a resource to support questions raised
by regulatory agencies.Key Accountabilities:
- Provides input to functional governance with Takeda's strategic
suppliers. - Partners with appropriate stakeholders to resolves
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.
- May prepare metrics to support the function's KPIs.
- 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.
- 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.
- Ensure 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 TFL standard
libraries.
- Leads and enforces maintenance and decommissioning of Clinical
Data Standards models (including but not limited to: CDASH, SDTM,
Controlled Terminology, ADaM, TFLs and questionnaires) through the
use of metadata repository. Includes regular assessment of
standards content with respect to compliance and industry
impacts.
- Performs other duties as assigned.Educational Qualifications:
- BS/BA required preferably in a health-related, life science
area or technology-related fields.Experience:
- Successful experience managing vendor relationships and
alliance partnerships with at least 4 years' experience in this
area.
- Minimum 3 years of line management experience or
equivalent.
- Experience with all phases of development in one or more
therapeutic areas preferred.
- Ability to handle multiple development programs
simultaneously.
- NDA/CTD Experience preferred.
- Solid understanding of clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and
processes.
- Expert knowledge of FDA and ICH regulations and industry
standards applicable to data capture and data management
process.
- Minimum of 10 years developing and managing clinical data
standards, or drug development process with expertise in the
cross-functional interfaces with Biometrics functions (e.g., Data
Management, EDC build, Statistical Programming &
Biostatistics)Behavioral Competencies:
- Pragmatic and willing to drive and support change.
- Is comfortable with ambiguity.
- Excellent teamwork, organizational, interpersonal, conflict
resolution and problem-solving skills.
- Entrepreneurial and innovative; takes measured risks; thinks
outside the box; challenge the status quo.
- Demonstrated strong matrix leadership and communication
skills.Job Complexity:
- High complexity at program that include multiple projects
and/or platforms.
- Domestic/international travel (5-20%) to other Takeda sites,
strategic partners, and therapeutic area events may be
required.Supervision:
- Minimal supervision required, should be able to function
independently and collaboratively with all levels of employees.Base
Salary Range: $ 137,200 to $ 196,000, based on candidate
professional experience level. -Employees may also be eligible for
Short Term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
Off. - -This posting is made in compliance with Colorado's Equal
Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.Absent an approved
religious or medical reason, all US office-based and lab-based
Takeda employees who work fully on-site or in a hybrid model (as
determined by Takeda) must be fully vaccinated to work at a Takeda
site or to engage with Takeda colleagues or anyone else on behalf
of Takeda. US field-based employees must be fully vaccinated as a
condition of employment, absent an approved religious or medical
reason. US employees who work at a Takeda manufacturing facility,
and those who work at a BioLife center or BioLife lab, may be
subject to different guidelines. If you are contacted by a Takeda
recruiter about your job application, we encourage you to seek more
information on the applicable guidelines for the Business
Unit/Function to which you have applied.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, Yonkers , Associate Director, Clinical Data Standards, Executive , Cresskill, New York
Didn't find what you're looking for? Search again!
Loading more jobs...