Yogesh Vana Patil

As a seasoned Clinical Data Management (CDM) professional with 10+ years of end-to-end experience, I aim to further explore the evolving landscape of clinical data and its impact on global healthcare. I am seeking challenging opportunities that allow me to leverage my expertise in data integrity, regulatory compliance, and cross-functional collaboration to contribute to innovative clinical trials. My goal is to continuously enhance my skills, embrace emerging technologies, and take on leadership responsibilities to mentor teams and drive strategic data initiatives within a dynamic organization. My expertise includes study setup, conduct and close-out activities in different therapeutic areas and platforms. Delivering trainings to new team member and enhancing process knowledge is my key interest.

• Therapeutic areas worked upon: Neuroscience, Immunology, Oncology, COVID and lightspeed trials, Medical Device trial, Cardiovascular
• Databases worked upon: Rave, Inform
• Experience of all the three phases of clinical data management i.e. Setup, conduct & closeout
• In Setup phase below activities, I have worked upon: Review the clinical trial protocol to understand data collection requirements and procedures, Preparing and maintain Data Management Plan (DMP) metrics, Preparation of quality control plan as per the SOPs, Writing eCRF specifications (ASL-Architect loader spreadsheet), Writing DVR specification and writing test cases, Preparation of protocol deviation document, Drafting eCRF completion guidelines, Creation of UAT plan, performing UAT and preparing UAT report, Worked on all the below mentioned UAT (Scripting, Testing & documentation): Database (SDS) UAT, Edit checks and derivations (Front end) UAT, Standard Data Review Model (SRDM) UAT, DRP and back-end checks (BE Checks) UAT, Non-CRF UAT for vendor data files, Preparing data transfer agreement (DTA) and Data file specifications (DFS) for vendor
• In Conduct phase below activities, I have worked upon: Performing regular discrepancy management on front end checks and the backend listings output in accordance with the agreed timelines, Reviewing all protocol deviations, Escalate any discrepancy in the clinical data to concerned designee, Identifying issues with validation procedures during study conduct and communicate finding concerned designee, Point of contact to monitor for data flow, discrepancy management, and all other data management related process, Communicating site data issues (dataflow, discrepancies, etc) with concerned designee, Co-ordinate with coding team for coding related activities, Requesting Reports from the programming team for various trackers and reports to be send to the study team, Creation and maintenance of Automated Clean Patient Tracker and study status metrics, Create and share the study metrics with the clinical team, Perform PPC or study migration, Performed reconciliations for below mentioned data types: Serious Adverse Event (SAE) reconciliation, IVRS/IWRS/IRT data reconciliation, E-dairy data reconciliation, PK/ADA Data reconciliation, Histogenex data reconciliation, Laboratory (Local as well as Central) data reconciliation, Perform local lab outlier’s data review, ECG reconciliation, Perform protocol deviation review and report the PD in PDIE module, Missing Pages report review, Biomarker Data Reconciliation
• In Close-out phase below activities, I have worked upon: Conduct a final review of study data to ensure completeness and accuracy, To ensure error free, quality data with no open queries prior to database lock, Co-ordinate with coding team for coding related activities, Perform P21 report review (Review dry run output), Perform locking and freezing of eCRFs, Perform domain wise review for SDTM Dataset before final submission, Generate final study reports summarizing the trial results and data collected, Archive study documents and other essential documents, according to regulatory requirements, Finalize the study database and lock it to prevent further data entry or modifications