Amit Kar Email & Phone Number

Bengaluru, Karnataka, India

Greater Kolkata Area

India

•Study Start-up experience includes study setup, defining data validation checks and their associated documentation, UAT (User Acceptance Testing) and Edit /validation checks, Creating CRF completion Guidelines, test conditions, working on Standards, and contributing to the development of SOPs.•Study conduct phase experience includes Discrepancy management- Front end (e-CRF) and Back-end Discrepancy review, SAE reconciliation, Vendor and external data reconciliation- PK, ADA and Lab… Show more •Study Start-up experience includes study setup, defining data validation checks and their associated documentation, UAT (User Acceptance Testing) and Edit /validation checks, Creating CRF completion Guidelines, test conditions, working on Standards, and contributing to the development of SOPs.•Study conduct phase experience includes Discrepancy management- Front end (e-CRF) and Back-end Discrepancy review, SAE reconciliation, Vendor and external data reconciliation- PK, ADA and Lab reconciliation and listings-review, SAS listing. Study status reporting, Quality control, and ongoing quality management of clinical trial data working on different study-specific reports and metrics.•Experience in Database Interim lock, Final lock, preparation of Lock checklist, Lock plan, accountable for signoff and achieve all documents.•Conducting kick-off meetings with CRO/Vendor team members before the study goes live and continue providing support in the data reconciliation process throughout the study.•Write edit check specifications along with listings and Edit check UAT and Documentation for Pre and Post production changes.•Assign all work assignments, commit the team to the work, manage the quality of the work and drive the people management activities within the team•Manage workloads to ensure even distribution of responsibilities and provide development opportunities•Assist in developing data management process and procedure improvements•Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization•Work with the Manager of CDM to create, modify and implement data management processes•Responsible for ensuring the integrity of data and providing recommendations for corrective action when necessary•Provides within and between-study comparisons of DM timelines for assigned projects. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve Show less

Kolkata Area, India

Kolkata, West Bengal, India

• Analyzes and interprets the medical record in its entirety to ensure accurate, complete and consistent selection of diagnoses and procedures to assure the production of quality healthcare data and accurate facility payment• Analyzes medical records for completeness of documentation and contacts physicians for clarification for any incomplete/ambiguous or conflicting documentation• As necessary, provides Physicians and other staff with information relative to coding• For outpatient… Show more • Analyzes and interprets the medical record in its entirety to ensure accurate, complete and consistent selection of diagnoses and procedures to assure the production of quality healthcare data and accurate facility payment• Analyzes medical records for completeness of documentation and contacts physicians for clarification for any incomplete/ambiguous or conflicting documentation• As necessary, provides Physicians and other staff with information relative to coding• For outpatient encounters, applies coding conventions and official coding guidelines approved by the Current Procedural Terminology (CPT) rules established by the American Medical Association (AMA), and any other official rules and guidelines established for use with the mandated outpatient procedure code sets• Performs in-depth analysis of medical records to abstract diagnoses and procedures Show less