Associate Clinical Data Base Validation Manager Job in Iqvia

Associate Clinical Data Base Validation Manager

Location: Thane

Job Overview:

The Associate Clinical Data Base Validation Manager will lead testing activities to ensure high-quality databases that meet customer requirements and regulatory standards. This role involves overseeing project planning, execution, and close-out phases, managing financial aspects, communication, and milestone deliverables while ensuring compliance with Good Clinical Practices (GCP), applicable regulatory guidelines, and internal SOPs.

Key Responsibilities:

Project Management & Planning:

• Attend Kick-Off meetings and regular project meetings until Study Go Live.
• Take full responsibility for creating the Edit Checks Test Plan document and writing test cases.
• Review the Project Plan, escalating any issues to stakeholders.

Testing & Validation:

• Release the Edit Checks Test Plan to the testing team and manage testing activities.
• Perform eCRF and Time & Events QC as per QC checklist.
• Review and escalate issues related to ASB and Edit Specification documents.
• Test email alerts and document changes in version history.
• Validate system configuration, including AUL, Rights and Roles, Home page, and System Settings.
• Provide project status updates on validation activities to the Data Team Lead and Lead Programmers.

Documentation & Reporting:

• Document all testing documentation in eDMSF in a timely manner.
• Maintain clear communication with internal customers and stakeholders.
• Review Testing Comments Log after each testing cycle and share it with programmers.
• Ensure accurate and timely documentation of all validation processes.

Team Leadership & Coordination:

• Coordinate with internal teams and ensure resources are assigned appropriately to meet project deliverables.
• Train and mentor Testing Team Members, providing leadership in validation processes.
• Implement proactive quality management plans and identify root causes of issues for remediation.
• Lead the team in driving changes across projects to improve processes and ensure compliance.

Quality & Financial Management:

• Review the QIP for appropriate budget allocation and communicate out-of-scope activities.
• Supervise implementation of new technology.
• Review individual project financial performance and communicate issues to stakeholders.
• Ensure adherence to study budgets.

Customer Relationships:

• Serve as the primary point of contact for internal customers regarding testing deliverables.
• Develop and maintain strong customer relationships and provide negotiation support for timelines, financials, and resources.

Qualifications:

Education:

• Bachelor s degree in Science, Computer Science, Information Technology, or Bachelor in Technology.

Experience:

• 4-6 years of relevant clinical database testing experience in Clinical Data Management Systems (CDMS) platforms.
• A total of 6+ years of relevant experience.

Skills & Competencies:

• Strong project management and leadership skills.
• Deep understanding of clinical data validation, testing processes, and database management.
• Ability to work cross-functionally and manage multiple projects simultaneously.
• Proficiency in MS Office, database management, and eDMSF systems.
• Strong communication and interpersonal skills for working with internal and external stakeholders.

Desired Attributes:

• Attention to Detail: Ability to meticulously track and validate database changes and project status.
• Problem-Solving Skills: Strong analytical skills to resolve complex testing and validation issues.
• Team Leadership: Proven experience in managing and mentoring a testing team, ensuring the quality and consistency of deliverables.
• Customer-Focused: Strong customer relationship skills to manage and exceed client expectations effectively.

This role offers an excellent opportunity for an experienced Clinical Data Base Validation Manager to drive successful clinical data management processes and enhance operational quality within a dynamic team. If you are a motivated professional with a strong background in clinical data validation and testing, we encourage you to apply.