Associate Director, Data Quality System Testing Expert
Takeda, Agawam, Massachusetts, us, 01001
Job Description
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Objectives / Purpose
Create and execute detailed test plans and UAT scripts based on business requirements and technical specifications to verify study/library functionality in the EDC system and adherence to standards.
Drive study database user acceptance testing activities, leading across multiple therapeutic areas and partnering closely with internal and external stakeholders to ensure the quality of the study build.
Collaborate with vendors and cross‑functional teams to build accurate integrations.
Ensure accurate delivery of study builds with quality deliverables per specification and participate in development, maintenance, and training around study build best practices.
Network with key stakeholders to refine and enhance study activities, automate build processes, and reduce testing needs.
Develop organizational knowledge of clinical data standards, key data sources, and systems, and be a valuable resource on automating study builds.
Provide technical leadership on clinical data flow, including building APIs for data extraction and integration.
Maintain SOPs, process maps, and templates that support operational and oversight models.
Define and lead continuous improvement initiatives, providing strategic direction and meeting timelines, budgets, and requirements.
Ensure data quality across databases, on‑time delivery, and quality of deliverables.
Lead UAT activities for studies and libraries in the EDC system, including inbound integrations following an Agile approach and applicable SOPs.
Develop UAT documentation such as Test Plans, UAT Scripts, and UAT Summary Reports.
Create and execute standardized test scripts for EDC components, inbound integrations, and data listings.
Record and document test results, compare to expected results, and detect software and specification failures for defect resolution.
Lead and coordinate End User Testing activities, ensuring testers have required training and system access.
Communicate actively with management and clinical teams about testing progress and challenges.
Support special projects and automated testing activities, including tool identification for manual UAT script automation.
Provide technical support, liaising with Clinical Data Engineering for troubleshooting and system issue resolution.
Demonstrate strong understanding of electronic data capture and clinical data management systems, clinical databases, data flow, and related infrastructure.
Have experience with EDC systems such as Veeva CDMS and Rave.
Accountabilities
Develop, maintain, and enhance testing strategies for EDC system study/library builds and integrations.
Coordinate and oversee end‑user testing activities, ensuring adequate training and system access.
Generate comprehensive UAT documentation, including Test Plans, UAT Scripts, and UAT Summary Reports.
Execute standardized test scripts for EDC components, inbound integrations, and data listings.
Record and compare test results to expected outcomes and identify failures for timely defect resolution.
Communicate testing progress, challenges, and outcomes to management and clinical teams.
Assist in special projects and automation initiatives, identifying tools for manual UAT script automation.
Collaborate with Clinical Data Engineering on troubleshooting and issue resolution.
Work with cross‑functional teams and vendors to ensure accurate and efficient system integrations.
Apply in‑depth knowledge of electronic data capture and clinical data management systems.
Apply experience with EDC systems such as Veeva CDMS, Rave, and related technologies (eCOA, IRT, RTSM, TSDV, CDR, MDR, SCE).
Education, Behaviours, Competencies and Skills
BS/BA or MS in Life Sciences, Computer Science, IT, Engineering, or a related field; approximately 10 years of experience in a CRO or pharmaceutical environment with a proven record of proactive management and innovation.
Experience with EDC and clinical data management systems.
Familiarity with clinical research technologies (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.
Previous experience leading medium to large organizations and influencing senior management and key stakeholders (plus).
Proven track record of leading business process transformation and organizational culture change.
Additional Information
Requires approximately 1‑2 domestic trips annually and up to 1 international trip.
Ability to sit, stand, and walk for long periods of time.
Capability to lift, carry, handle, and reach for objects.
Manual dexterity to operate office equipment (computers, phones, etc.).
This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy.
Compensation and Benefits Summary Location:
Massachusetts – Virtual
U.S. Base Salary Range:
$153,600.00 – $241,340.00
The 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, 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 or performs 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. They may also participate in medical, dental, vision insurance, a 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, well‑being benefits, and other programs. U.S. based employees are eligible to accrue up to 80 hours of sick time per calendar year, 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 – Virtual
Worker Type Employee
Worker Sub‑Type Regular
Time Type Full time
Job Exempt: Yes
It 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.
#LI-Remote
#J-18808-Ljbffr
Objectives / Purpose
Create and execute detailed test plans and UAT scripts based on business requirements and technical specifications to verify study/library functionality in the EDC system and adherence to standards.
Drive study database user acceptance testing activities, leading across multiple therapeutic areas and partnering closely with internal and external stakeholders to ensure the quality of the study build.
Collaborate with vendors and cross‑functional teams to build accurate integrations.
Ensure accurate delivery of study builds with quality deliverables per specification and participate in development, maintenance, and training around study build best practices.
Network with key stakeholders to refine and enhance study activities, automate build processes, and reduce testing needs.
Develop organizational knowledge of clinical data standards, key data sources, and systems, and be a valuable resource on automating study builds.
Provide technical leadership on clinical data flow, including building APIs for data extraction and integration.
Maintain SOPs, process maps, and templates that support operational and oversight models.
Define and lead continuous improvement initiatives, providing strategic direction and meeting timelines, budgets, and requirements.
Ensure data quality across databases, on‑time delivery, and quality of deliverables.
Lead UAT activities for studies and libraries in the EDC system, including inbound integrations following an Agile approach and applicable SOPs.
Develop UAT documentation such as Test Plans, UAT Scripts, and UAT Summary Reports.
Create and execute standardized test scripts for EDC components, inbound integrations, and data listings.
Record and document test results, compare to expected results, and detect software and specification failures for defect resolution.
Lead and coordinate End User Testing activities, ensuring testers have required training and system access.
Communicate actively with management and clinical teams about testing progress and challenges.
Support special projects and automated testing activities, including tool identification for manual UAT script automation.
Provide technical support, liaising with Clinical Data Engineering for troubleshooting and system issue resolution.
Demonstrate strong understanding of electronic data capture and clinical data management systems, clinical databases, data flow, and related infrastructure.
Have experience with EDC systems such as Veeva CDMS and Rave.
Accountabilities
Develop, maintain, and enhance testing strategies for EDC system study/library builds and integrations.
Coordinate and oversee end‑user testing activities, ensuring adequate training and system access.
Generate comprehensive UAT documentation, including Test Plans, UAT Scripts, and UAT Summary Reports.
Execute standardized test scripts for EDC components, inbound integrations, and data listings.
Record and compare test results to expected outcomes and identify failures for timely defect resolution.
Communicate testing progress, challenges, and outcomes to management and clinical teams.
Assist in special projects and automation initiatives, identifying tools for manual UAT script automation.
Collaborate with Clinical Data Engineering on troubleshooting and issue resolution.
Work with cross‑functional teams and vendors to ensure accurate and efficient system integrations.
Apply in‑depth knowledge of electronic data capture and clinical data management systems.
Apply experience with EDC systems such as Veeva CDMS, Rave, and related technologies (eCOA, IRT, RTSM, TSDV, CDR, MDR, SCE).
Education, Behaviours, Competencies and Skills
BS/BA or MS in Life Sciences, Computer Science, IT, Engineering, or a related field; approximately 10 years of experience in a CRO or pharmaceutical environment with a proven record of proactive management and innovation.
Experience with EDC and clinical data management systems.
Familiarity with clinical research technologies (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.
Previous experience leading medium to large organizations and influencing senior management and key stakeholders (plus).
Proven track record of leading business process transformation and organizational culture change.
Additional Information
Requires approximately 1‑2 domestic trips annually and up to 1 international trip.
Ability to sit, stand, and walk for long periods of time.
Capability to lift, carry, handle, and reach for objects.
Manual dexterity to operate office equipment (computers, phones, etc.).
This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy.
Compensation and Benefits Summary Location:
Massachusetts – Virtual
U.S. Base Salary Range:
$153,600.00 – $241,340.00
The 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, 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 or performs 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. They may also participate in medical, dental, vision insurance, a 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, well‑being benefits, and other programs. U.S. based employees are eligible to accrue up to 80 hours of sick time per calendar year, 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 – Virtual
Worker Type Employee
Worker Sub‑Type Regular
Time Type Full time
Job Exempt: Yes
It 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.
#LI-Remote
#J-18808-Ljbffr