Associate Director, Data Quality System Testing Expert
Takeda, Boston, Massachusetts, us, 02298
Associate Director, Data Quality System Testing Expert
Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below. Join to apply for the
Associate Director, Data Quality System Testing Expert
role at
Takeda
Base pay range: $153,600.00/yr - $241,340.00/yr
Responsibilities
Create and execute detailed test plans and UAT scripts based on business requirements and technical specifications to verify study/library functionality in EDC system and adherence to standards.
Drive study database user acceptance testing activities in a role that requires leadership across multiple therapeutic areas and the ability to partner closely with internal/external stakeholders to ensure the quality of the study build in the EDC system.
Collaborate with various vendors and cross functional teams to build to ensure accuracy of any integration.
Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices used by business.
Network with key business stakeholders on refining and enhancing the activities around study to automate the study build and reduce the need for testing.
Develop organizational knowledge of clinical data standards, key data sources, systems and be a valuable resource to people in the company on how to effectively automate study build to pursue company objectives. Provides technical leadership on various aspects of clinical data flow including build APIs to various systems for data extraction and integration.
Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
Defines and/or leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data deliverables.
Lead UAT activities for studies and libraries in EDC system, including inbound integrations with an Agile Approach according to applicable SOPs (standard operating procedures) and processes.
Develop UAT documentation such as Test Plans, UAT Scripts, UAT Summary Report and etc.
Create and execute standardized test scripts for EDC components, inbound integrations, and data listings.
Record and document test results and compare to expected results. Detect software and specifications failures, so that defects may be discovered and corrected.
Lead and coordinate End User Testing Activities, ensure that End User 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 CDE for troubleshooting and system issue resolution.
Collaborate with cross-functional teams and vendors to ensure integration accuracy.
Demonstrate strong understanding of electronic data capture and clinical data management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC systems such as Veeva CDM.
Qualifications
BS/BA or MS in a Life Science, Computer Science, IT, Engineering, or related field or analytical area with ~10 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation.
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.
Previous experience leading a medium to large organization and influencing senior‑level management and key stakeholders is a plus.
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
Additional Information
Requires approximately 1 - 2 domestic trips annually and up to 1 international trip.
Ability to sit and stand for long periods of time. xsgimln
Carrying, handling, and reaching for objects.
Manual dexterity to operate office equipment i.e., computers, phones, etc.
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.
Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below. Join to apply for the
Associate Director, Data Quality System Testing Expert
role at
Takeda
Base pay range: $153,600.00/yr - $241,340.00/yr
Responsibilities
Create and execute detailed test plans and UAT scripts based on business requirements and technical specifications to verify study/library functionality in EDC system and adherence to standards.
Drive study database user acceptance testing activities in a role that requires leadership across multiple therapeutic areas and the ability to partner closely with internal/external stakeholders to ensure the quality of the study build in the EDC system.
Collaborate with various vendors and cross functional teams to build to ensure accuracy of any integration.
Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices used by business.
Network with key business stakeholders on refining and enhancing the activities around study to automate the study build and reduce the need for testing.
Develop organizational knowledge of clinical data standards, key data sources, systems and be a valuable resource to people in the company on how to effectively automate study build to pursue company objectives. Provides technical leadership on various aspects of clinical data flow including build APIs to various systems for data extraction and integration.
Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
Defines and/or leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data deliverables.
Lead UAT activities for studies and libraries in EDC system, including inbound integrations with an Agile Approach according to applicable SOPs (standard operating procedures) and processes.
Develop UAT documentation such as Test Plans, UAT Scripts, UAT Summary Report and etc.
Create and execute standardized test scripts for EDC components, inbound integrations, and data listings.
Record and document test results and compare to expected results. Detect software and specifications failures, so that defects may be discovered and corrected.
Lead and coordinate End User Testing Activities, ensure that End User 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 CDE for troubleshooting and system issue resolution.
Collaborate with cross-functional teams and vendors to ensure integration accuracy.
Demonstrate strong understanding of electronic data capture and clinical data management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC systems such as Veeva CDM.
Qualifications
BS/BA or MS in a Life Science, Computer Science, IT, Engineering, or related field or analytical area with ~10 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation.
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.
Previous experience leading a medium to large organization and influencing senior‑level management and key stakeholders is a plus.
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
Additional Information
Requires approximately 1 - 2 domestic trips annually and up to 1 international trip.
Ability to sit and stand for long periods of time. xsgimln
Carrying, handling, and reaching for objects.
Manual dexterity to operate office equipment i.e., computers, phones, etc.
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.