Clinical DB Validation Specialist

IQVIA LLC; Ernakulam; On-site; INR 900,000 - 1,200,000; Full time

Job summary

IQVIA LLC in India seeks a Validation Tester to conduct testing activities across CDMS platforms like Inform, RAVE, OCRDC, and Oracle Clinical, ensuring data integrity and compliance.

You may lead validation projects under supervision, develop test plans, and mentor junior associates while coordinating with the Data and Validation teams to meet project deadlines.

Qualifications

• Bachelor's degree in Science, CS/IT or BTech.
• 2–4 years of clinical DB testing experience in CDMS platforms.
• Total experience of 4+ years.

Responsibilities

• Independently conduct testing activities to validate Edit Checks, SAS listings, Transfer programs and custom reports in platforms like Inform, RAVE, OCRDC, Oracle Clinical.
• Support Validation Team Leads and contribute to test case creation, documentation and communication with internal customers.
• Assist in managing validation projects and deliverables, with potential leadership responsibilities.
• Maintain documentation and ensure compliance with validation procedures and best practices.
• Provide status updates to Validation Team Lead/Manager and participate in knowledge sharing sessions.

Skills

Testing expertise

Validation support

Team mentoring

Documentation

Education

Bachelor's degree in Science/CS/IT or BTech

Job description

Job Overview

Conduct testing activities and provide comprehensive testing expertise to produce efficient, quality database that meets customer requirements. Provide support in creation of Test Plan and handling of validation projects. May act as Validation Team Lead. May undertake selected team leadership activities under supervision of Manager.

Essential Functions

• Independently conduct testing activities to validate Edit Checks, other components, SAS listings, Transfer program and custom reports in platforms like Inform, RAVE, OCRDC, Oracle Clinical. Should have high expertise in Testing activities and excellent knowledge of Database.
• Advanced understanding of database structures.
• Perform eCRF and Time & Events QC as per QC checklist.
• Provide support to Validation Team Leads as required and contribute towards creation of test cases, documentation and communication with internal customers.
• Support Validation Team Lead in overall management of validation projects. May take complete responsibility for delivery of a validation project.
• Understand all the documentation requirements with regards to validation very well and update all relevant documents in a timely manner. May monitor documentation compliance for junior team members.
• Ensure validation processes and best practices are being followed strictly by self and team. May assist with creation/review of now processes/best practices.
• Communicate status of the projects to the Validation team Lead/Manager/ Data Team Lead/Programmer.
• Support Validation Team Lead/Manager with daily tasks allocation for validation projects.
• Escalate problems to the attention of the Validation team Lead or Manager.
• Conduct Quality Reviews of Testing projects on an ongoing basis as applicable.
• Conduct Knowledge Sharing and Lessons Learnt sessions regularly.
• Review and update relevant documents accurately and completely on time. May document all testing documentation in eDMSF.
• May serve as Subject Matter Expert (SME).
• Mentor Associate Validation Analysts/Validation Analysts in all validation activities.
• May provide metrics support to Validation Team Lead or Manager.
• Identify areas for process improvements continuously. Actively take part and contribute towards process improvement initiatives s assigned besides providing suggestions/ideas for continuous improvement of the process.
• Understand and comply with core Operating Procedures and Work Instructions (including Best Practice and Guidance documents).
• Meet project objectives as assigned by Validation Team Lead or Manager.
• Develop and maintain good communication and working relationships with validation teams across sites.

Qualifications

• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology.
• 2- 4 years of relevant clinical DB Testing experience in CDMS Platforms and total exp being 4+ yrs.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.