Senior Manager, Clinical Data Standards
Company: Takeda Pharmaceutical
Location: Levittown
Posted on: May 9, 2022
Job Description:
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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 DescriptionREMOTE JOB OPPORTUNITY!Job Title:Senior
Manager, Clinical Data StandardsReports to:Director, Head, Clinical
Data StandardsTakedaTakeda 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 guided by
integrity, one of Takeda's long-held values that extends to both
the patients we serve and our employees who develop 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 main focus areas;
gastroenterology, oncology, neuroscience, plasma-derived therapies,
rare diseases and vaccines. Boston (Massachusetts) is the R&D
headquarters.Senior Manager, Clinical Data StandardsA the Senior
Manager Clinical Data Standards, you will oversee the development,
deployment, management and governance of clinical standards. They
are Takeda's Data Standards Leaders and SMEs, actively engaged in
Data Standards forums (internally or externally) to maintain
awareness of any plans and trends that could be incorporated into,
or enhance Takeda's Clinical Data Standards Library.You will lead
the identification, review/evaluation, deployment and usage of
technologies to distribute and integrate with and report on
standards compliance internally and collaboratively with
CROs/strategic service providers.Key Accountabilities
- Represent Takeda and Global Development Operations as a member
of Standards Development Organization or Standard Support Groups
(e.g. CDISC, PhUSE).
- Contribute and lead functional Continuous Improvement plans,
providing strategic direction and identifying essential
deliverables that meet timelines, budget, and are with company,
departmental requirements.
- Ensure compliance with own Learning Curricula, corporate and
GXP requirements.
- Lead and contribute to the development of Clinical Data
Standards models (including): CDASH, SDTM, Controlled Terminology,
TFLs and questionnaires). Includes periodic assessment of standards
content for compliance and industry impacts.
- May lead the assessment, implementation and governance of
systems and tools to support on standards
- Lead the development of project plans; determine risks and
recommend contingency plans.
- Lead standards compliance review and works with departments and
CROs/strategic service providers to strengthen content and
interpretation of Takeda standards
- Be a Standards area project manager or team leader for selected
standards projects and teams.
- Develop strategy for Standards Management technology selection
and deployment across Clinical Studies with established Takeda SOPs
and Policies, and governance models.
- Oversee Standards delivery life cycle, including deployment
strategies, Communications, User training and
management.Educational Qualifications
- BS/BA required preferably in a health-related, life science
area or technology-related fields.Requirements
- Project management experience managing clinical data standards
activities for large drug development programs.
- Advanced knowledge of broad drug development process with
expertise in Data Management & Data Standards.
- 8 years data standards and drug development process with
expertise in the data management function.
- Experience with budget planning and management.
- Knowledge of relational databases and experience using multiple
clinical data management systems.
- Knowledge of general medical coding in the
pharmaceutical/biotechnology industry including knowledge of
medical dictionaries, coding tools, and coding governance
models.
- Working knowledge of CDASH, SDTM or ADaM, and CDISC controlled
Terminology.
- Working knowledge of clinical trial terminology and Architect
Loader Specification
- Knowledge of XML, ALS and MDRBase Salary Range:
$150,000-170,000 based on candidate professional experience level.
Employee may also be eligible for Short Term and Long Term
incentive benefits. Employees are eligible to participate in
Medical, Dental. Vision, Life Insurance, 401(k), Charitable
Contribution Match, Company Holidays, Personal & Vacation Days,
Student Loan Repayment Program and Paid Volunteer Time Off.If
candidate is not eligible for any benefits or other comp., those
can be excluded.This posting is made in compliance with Colorado's
Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.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.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Levittown , Senior Manager, Clinical Data Standards, Executive , Levittown, New York
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