Clinical DB Validation Specialist

IQVIA; Ernakulam; On-site; INR 600,000 - 1,000,000; Full time

Job summary

IQVIA in India seeks a Validation/Test Analyst to conduct testing across CDMS platforms (Inform, RAVE, OCRDC, Oracle Clinical), develop test plans, and support validation project delivery.

You will mentor associates, ensure documentation and SOP compliance, and communicate progress to managers. A Bachelor's degree and 4+ years in clinical DB testing are required.

Qualifications

• Degree in Science/CS/IT or Technology required.
• 2–4 years of clinical database testing in CDMS platforms; total experience is 4+ years.

Responsibilities

• Conduct testing to validate Edit Checks, SAS listings, and transfers.
• Support creation of Test Plans and validation documentation.
• Mentor junior analysts and support validation leads.
• Ensure compliance with validation processes and SOPs.

Skills

Testing

Database knowledge

Validation

Mentoring

Leadership

Education

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

4+ years total exp in clinical DB Testing

Tools

Inform

RAVE

OCRDC

Oracle Clinical

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.
• All responsibilities are essential job functions unless noted as nonessential (N).

Qualifications

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

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.