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 the Senior Manager Clinical Data Standards, where you will oversee the development, deployment, management, and governance of clinical standards. Along with other Takeda Data Standards Leaders and SMEs, you will be 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
How you will contribute:
- Represent Takeda and Data Science Institute as a member of Standards Development Organization or Standard Support Groups (e.g., CDISC, PHUSE).
- Contribute and may lead functional Continuous Improvement plans, identifying essential deliverables that meet timelines, budget, and are with company, departmental requirements.
- Ensure compliance with own Learning Curricula, corporate and GXP requirements.
- Create standards specification for collection, tabulation, control terminology, edit checks etc. coming from study requests.
- Respond to study teams and provide the best practices to map data.
- May lead and contribute to the development of Clinical Data Standards models (including): CDASH, SDTM, Controlled Terminology, questionnaires, ADaM and TLFs. Includes periodic assessment of standards content for compliance and industry impact.
- May lead the assessment, implementation and governance of systems and tools to support standards.
- May lead projects; 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.
- Contribute to Standards Management technology deployment across Clinical Studies with established Takeda SOPs and Policies, and governance models.
- Contribute to Standards delivery life cycle, including deployment strategies, Communications, User training and management.
- BS/BA required preferably in a health-related, life science area or technology-related fields.
- 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, reporting, standards function.
- 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 MDR.
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- 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 and company match of charitable contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
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.
Base Salary Range: $ 130,000 to $ 186,000, 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
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
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
Massachusetts - VirtualWorker Type