Job Description
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Job Description
Objective / Purpose:
Support R&D clinical development delivery by serving as the senior business system administration leader and operational owner for assigned clinical and operational data platforms, establishing a consistent administration operating model, access management and controls, study and system release readiness, intake and tiered support, and inspection-ready GxP documentation to enable reliable adoption, high-quality user experience, and continuous improvement across programs.
Accountabilities:
- Own the system administration operating model for supported clinical and operational systems, including standardized ways of working, controls, and continuous improvement to optimize end-user experience and service outcomes.
- Lead the business system administrator team by setting priorities and expectations, coaching performance, building capability/coverage, and ensuring consistent execution across administration, training, and support activities.
- Manage the intake/inbox process end-to-end, including triage, prioritization, SLAs, KPIs, escalation paths, and routine performance reporting to stakeholders with actions to improve timeliness and quality.
- Act as the business system administration leader and technology SME for supported systems, providing guidance on capabilities and standards and ensuring consistent best-practice application across studies/teams and partners.
- Own demand and backlog for administration and support enhancements; partner with Product Team and BSOs to define requirements, plan releases/upgrades, participate in testing/readiness (where applicable), and ensure smooth cutover and stabilization.
- Contribute to vendor governance by participating in routine touchpoints, ensuring adherence to defined processes and deliverables, escalating risks/issues, and driving consistent execution across internal and external stakeholders.
- Accountable for access management, including role implementation, approvals, periodic access reviews/audits, and timely remediation and documentation.
- Oversee role-based training assignments and end-user enablement materials, including maintaining training curricula, supporting development of materials and job aids, and managing knowledge content aligned to process and system changes.
- Collaborate with adoption leads to deliver SET-facing communications and guidance, and establish structured feedback loops to improve usability, adoption, and resolution quality.
- Ensure tiered support and service management, including incident and problem management, escalation coordination, documented outcomes/closure, and root-cause trending with corrective and preventive actions to reduce recurrence.
- Accountable for GxP system administration documentation and evidence (SOPs/WIs, work practices, records), archival and inspection readiness, and representing the function in audits/inspections including coordination of auditor/inspector access as needed.
Education & Competencies (Technical and Behavioral):
- Bachelor’s degree (BS/BA) required in health/life sciences or technology-related field; or commensurate experience.
- Minimum 6 years drug development and pharma/project administration/administrative experience with clinical and operational systems preferred (e.g., EDC, CTMS, eTMF, etc).
- Demonstrated knowledge of SDLC and applicable GxP/ICH/FDA expectations; experience supporting clinical technologies and/or operational data systems
- Strong project management, stakeholder management, and written/verbal communication skills; able to work effectively in a complex matrix/global environment.
- Data stewardship and compliance mindset (data quality/governance principles; managing standards and end-user compliance).
ADDITIONAL INFORMATION:
- This position is currently classified as “remote” by 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:
Massachusetts - VirtualU.S. Base Salary Range:
$137,000.00 - $215,270.00The 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-term incentives. 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
Massachusetts - VirtualWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Originally posted on Himalayas
