Associate Director, Data Quality System Testing Expert
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Job Description
Associate Director leading data quality system testing for clinical trials at Takeda. Ensuring adherence to standards and facilitating collaboration with vendors and stakeholders.
Responsibilities:
- Create and execute detailed test plans and UAT scripts
- Drive user acceptance testing activities and ensure quality of study builds
- Collaborate with vendors and cross-functional teams
- Maintain SOPs and support continuous improvement initiatives
- Ensure accurate delivery of study build with quality deliverables
- Lead UAT activities for studies and libraries in EDC system
- Develop and document comprehensive UAT documentation
- Communicate actively with management and clinical teams about testing progress
Requirements:
- BS/BA or MS in a Life Science, Computer Science, IT, Engineering, or related field
- ~10 years of experience in a CRO/pharmaceutical environment
- Experience with EDC and clinical data management systems
- Familiarity with clinical research technologies (e.g., eCOA, IRT, RTSM)
- Experience in software testing and quality assurance
- Proficiency in Agile methodologies and adherence to SOPs
- Understanding of clinical data management processes and regulations
- Strong problem-solving skills and attention to detail
- Proven record of leading and driving business process transformation and organizational culture change
Benefits:
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) plan and company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Up to 80 hours of sick time
- Up to 120 hours of paid vacation
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