Experience

JSS Medical Research

• Canada
• Biotechnology Research
• 300 - 400 Employee

• Senior Clinical Manager

  • Feb 2018 - Present

   Performed data review activities, discrepancy management, listing review, closing queries, quality control and  Reporting to lead manager and operations coordinator for study related clarifications.  Interacted with the sites and CRA to coordinate error resolution using data clarification forms  Generated and resolved queries via Oracle Clinical, RAVE and InForm.  Contributed towards fine-tuning of standard DM processes, in collaboration with global colleagues.  Identifying and implementation of best practices for DM.  Executed SAE reconciliation and external vendor data reconciliation for several clinical trials  Responsible for supporting database locking activities, including planning and executing listing reviews and identifying remaining clinical and monitoring tasks Involved in development of case report forms and CRF completion guidelines and edit checks.  Ensuring data entry, data validation is as per protocol requirements.  Applying quality control procedures and ensuring standardized data quality is achieved.  Update, track, and maintain study specific trial management tools/system.  Performed clinical data management activities including strategy, process, quality, compliance.  Performed data review, UAT testing, Ad Hoc listing review, database lock check listing review.  Mentoring co-workers and performing peer QC. Show less



GRAVITAS BIOSCIENCES Pvt Ltd

• Hyderabad, Telangana, India

• Clinical Data Manager II

  • Jul 2013 - Nov 2015

   Participated in Study start-up, conduct and close-out phases.  Involved in the preparation of DMP and eCRF completion guidelines and other DM related documents. Designed case report forms (CRFs)  Assisted in Database Designing including activities like developing Study Design Requirement (SDR), Edit Check Specification (ECS) and performing User Acceptance Test (UAT)  Performed Database lock activities, like planning and executing listings review, identifying remaining clinical and monitoring tasks  Provide inputs to the Manager on resources, scheduling and timelines as required.  Performed Quality Check (QC) of the data by manual review  Generated and reviewed EDC/UAT functionality and Edit Checks  Developed and executed queries in clinical databases  Designed, created, and reviewed CRF Completion Guidelines document  Performed Lab, SAE, and external-vendor data reconciliation in several clinical trials  Contributed towards developing guidelines/checklist that aids in streamlining of activities for Data Management (DM) during study close-out.  Communicated and coordinated with different global teams in various studies  Performed clinical data interim analysis. Show less