Data Quality System Testing Consultant

Position: Data Quality System Testing Consultant

Experience: 10+ Years

Mode: Remote

Time: US EST Hours

Objective / Purpose:

• Create and execute detailed test plans and UAT scripts in Excel and /or ALM testing system based on business requirements and technical specifications to verify study/library functionality in Veeva CDMS and/or Rave EDC system and adherence to standards.
• Drive study database user acceptance testing activities and ensure the quality of the study build in the EDC system.
• 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.
• 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.
• Communicate actively with management and clinical teams about testing progress and challenges.
• 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 CDMS and Rave, Veeva CDB, elluminate Data Central, EHR, eCOA, IRT, RTSM, TSDV, DMR and adjacent systems.

Accountabilities:

Test Plan and Script Execution:

• Create and execute detailed test plans and User Acceptance Testing (UAT) scripts, ensuring alignment with business requirements and technical specifications.
• Validate study/library functionality within EDC systems and confirm adherence to established standards.

Testing Strategy Development:

• Develop and enhance testing strategies for EDC system study/library builds and integrations

  UAT Documentation Development:

• Develop comprehensive UAT documentation, including Test Plans, UAT Scripts, and UAT Summary Reports.

  Standardized Test Script Creation:

• Develop and execute standardized test scripts for EDC components, inbound integrations, and data listings.

Testing Results Analysis:

• Record and document test results, comparing them to expected outcomes.
• Identify software and specification failures for timely defect resolution.

  Communication and Reporting:

• Actively communicate with management and clinical teams about testing progress, challenges, and outcomes.

  Support for Special Projects:

• Assist in special projects and automated testing initiatives, including the identification of tools for manual UAT script automation.

Cross-functional Collaboration:

• Work closely with cross-functional teams and vendors to ensure accuracy and efficiency in system integrations.

  Expertise in Clinical Data Systems:

• Demonstrate in-depth knowledge of electronic data capture, clinical data management systems, and related infrastructure.
• Utilize experience with various EDC systems (e.g., Veeva CDMS, Rave) and related clinical research technologies (e.g., eCOA, IRT, RTSM).

Core Elements Related to this Role:

• Thorough knowledge and understanding of test case development processes, focused on clinical data with a strong knowledge of clinical study design in EDC and an understanding of clinical data management operations.
• Proven track record in development and management of test documentation including Test Plans, Test Scripts and Test Summary reports and in-depth knowledge of study design through submission.

Technical/Functional (Line) Expertise

• Comprehensive understanding of the pharmaceutical industry and clinical development.
• Functional level expertise of testing and validation of clinical systems.
• Comprehensive understanding of medical concepts, clinical data flow and systems used in the clinical space.
• Hands-on experience and knowledge of the various components of EDC system and clinical study lifescycle.
• Good knowledge of clinical systems and tools (e.g. Veeva CDMS, Rave EDC, Veeva CDB, Elluminate)
• Desirable technical expertise (e.g., Windows NT and UNIX operating systems) and familiarity with common test case management software, familiarity with ALM, UFT, Tosca and Qtest.
• Expertise in the requirements and technology required to support electronic data capture and electronic submissions.

Interaction

• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace.
• Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
• Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner.
• Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions.
• Proven track record in identifying and implementing organization-wide initiatives, standards, and processes.

Innovation

• Forward thinking with the ability to recommend, influence and implement organizational change and continuous improvement.
• Comfortable challenging the status quo and bringing forward innovative solutions.
• Ability to take risks implementing innovative solutions, accelerating time to market.
• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
• Role models respect and inclusion, creating a culture that fosters innovation.
• Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo.

Complexity

• Ability to work in a global ecosystem (internal and external) with a medium to high degree of complexity.
• Ability to see and understand broader, enterprise level perspective as well as from collection through submission perspective.

Education & Competencies (Technical and Behavioral):

• 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.

dsingh15@fcsltd.com