•Having through knowledge on Drug development process from phase - I to IV.•1.5 years’ experience as eTMF Specialists.•Responsible for maintaining Data Management component of Trial Master File.•Experience working on various platforms like Inform GT 5.5, OC, RDC, Rave, Medrio,Veeva Vault.•Excellent verbal and written communication skills; efficient interpersonal skills, leadership and teamwork abilities.•Responsible for performing the Data Management activities for clinical studies in accordancewith the customer’s expectations, DMP, Protocol, CRFs, relevant SOPs and ICH GCP.•Effective time management skills due to strict timelines work and multitasking abilities.•Support regulatory and client audits of validation activities and documents. •Review EDC specifications from Specification Author. Writes and assembles critical validation documentation packages including the Validation Plan, Testing Results, Traceability Matrix and Validation Report.•Provide coordination of virtual global validation teams as needed to complete validation projects.•Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards•in relation to the System Development Life Cycle.•Execute test cases against these requirements, enter errors into error tracking logs, perform retests documenting resolutions, and maintain validation testing documentation within the electronic trial master file.•Responsible for developing and maintaining the Data Management Plan (DMP)•Regularly reviews project documentation to ensure that all documents are up-to-date, appropriately version controlled, and that filing is up to date, including provision to client and filed in Trial Master File as appropriate•Coordinates user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import/export programs, and medical coding during study build. Drives the development of the edit checks.

Worked on Data base Lock activities.Worked on Projects with such as Screen Testing, UAT, Conduct Activities such as Discrepancy Management, Vendor Data Reconciliation, Reporting and Closeout Activities such as freezing, locking., Performed Discrepancy Management and Query tracking.Support multiple therapeutic areas. Training of new joiners as a part of their induction, delivering training as well as mentoring new joiners.

Performed Data entry as per required data entry guidelines. Coding of drugs, and Adverse events, Case processing, Running Batch Validation against the specified e-CRFs.− Develop and maintain good communications and working relationships within CDM and Cross-functional team members.− Mentoring and supporting the new staff technically and morally.− Performed Discrepancy Management and Query tracking.− Creating TMF for Various Studies.