Clinical DB Validation Specialist

Overview

Conduct testing activities and provide testing expertise to produce an efficient, quality database that meets customer requirements, with support in test plan creation and validation project handling. May act as Validation Team Lead or undertake selected team leadership activities under supervision of a Manager.

What you'll do

• Independently conduct testing activities to validate Edit Checks, other components, SAS listings, Transfer program and custom reports in platforms such as Inform, RAVE, OCRDC and Oracle Clinical.
• Perform eCRF and Time & Events QC as per the QC checklist.
• Provide support to Validation Team Leads and contribute to creation of test cases, documentation and communication with internal customers.
• Support the Validation Team Lead in overall management of validation projects, and take complete responsibility for delivery of a validation project where assigned.
• Understand validation documentation requirements and update all relevant documents in a timely manner; monitor documentation compliance for junior team members.
• Ensure validation processes and best practices are followed by self and team; assist with creation or review of new processes and best practices.
• Communicate project status to the Validation Team Lead, Manager, Data Team Lead and Programmer.
• Support the Validation Team Lead or Manager with daily task allocation for validation projects and escalate problems to them.
• 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; document all testing documentation in eDMSF.
• Serve as Subject Matter Expert (SME) where required.
• Mentor Associate Validation Analysts and Validation Analysts in all validation activities.
• Provide metrics support to the Validation Team Lead or Manager where required.
• Identify areas for process improvement continuously, actively take part in assigned improvement initiatives and provide suggestions for continuous improvement.
• Understand and comply with core Operating Procedures and Work Instructions, including Best Practice and Guidance documents.
• Meet project objectives as assigned by the Validation Team Lead or Manager.
• Develop and maintain good communication and working relationships with validation teams across sites.

What you'll need

• Bachelor's degree in Science, Computer Science, Information Technology or Technology.
• 2-4 years of relevant clinical database testing experience on CDMS platforms, with total experience of 4+ years.
• Excellent knowledge of databases and high expertise in testing activities.
• Advanced understanding of database structures.

Details

• Location: Kochi, India.