Khyati Mehta

Clinical Db Validation Specialist @IQVIA

As a Validation Team Lead, responsible of primarily going through Specification and throughthe SOPs.• Review of Specification & NCG.• Preparing TC (Test Cases).• Review of TC.• Performing Data Entry.• Performing Validation.• Working on Transfer & Vendor Transfer Validation.• Working on Import test file & Validation.• Performing QC of the documents.Responsibilities:• Attend Kick Off Meeting and regular project meetings until Study Go Live.• Take complete responsibility for creation of Data Review Test Plan document and writing testcases.• Release the Data Review Checks Test Plan to the testing team to conduct testing activities.• Review Project Plan and escalate issues (if any) to all stakeholders.• Comprehend study protocol and share the basic requirement of protocol with validation projectteam.• Review ASB, Data Review and Edit Specification document, provide input and escalate issuesif any.• Document in version history if any changes made to Data review Specifications within TestPlan during validation process.• Provide project status updates on validation activities to Data Team Lead/Lead Programmers.• Review Testing Comments Log after each cycle of testing and provide Testing Comments Logto Programmer.• Co-ordinate with internal Customers on a regular basis.• Work with functional manager(s) to ensure appropriate resources are assigned to meet projectdeliverables.• Continuously look for opportunities to improve the process; work with team to develop andimplement plan to re-organize and drive change across multiple projects/programmed (withminimal support)• Ensure timely follow-up and resolution of compliance issues.• Train and mentor Testing Team Members.• Escalate risks to the Manager.• Conduct Quality Reviews as applicable.• Ensure adherence to study budget.• Serve as primary point of contact for Internal Customers on testing deliverables.• Develop and maintain strong Customer relationships.