Dipak C.

Experience

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  Diabetes Care Clinics

  May 2008 - May 2017

  Site Manager-Clinical Research Coordinator

  ➢Performed clinical trial procedures according to protocol, ICH-GCP guidelines, Schedule-Y and respective regulatory authority requirements ➢ Communicates with CRA, patients, central lab, local lab, IVRS, IWRS, ERT, PHT for e-diary and other ancillary services related to ongoing trial protocol ➢ Responsible to update paper CRF/ eCRF (EDC, Oracle Inform, Medidata rave, OCRDC, Bioclinica, nextrials), Resolved and maintain the eCRF queries (DCF’s) within suggested timelines ➢ Responsible for Ethics Committee regarding EC Submissions, Notifications and Approvals related to protocols and site ➢ Responsible to update, review and maintained patient and study drug related logs, IP Shipment/Accountability logs and other Trial Master File documents like-EC submissions EC approvals, EC notifications, Updated FDA1572, Investigator undertaking, Study staff CV’s and FD’s, Delegation logs, CDA, feasibility questionnaires, finalized the budget of studies and maintained the other miscellaneous documents ➢ Responsible to Track and update patient summery, source documents, medical history, eligibility criteria as per given protocol requirements ➢ Responsible to Track Protocol Deviations, Protocol Violations AE, SAE, CIOMS, SUSAR, 6 Month line listing and other study material at site ➢ Scheduled and attend site selection, site initiation, site monitoring and site close out visit at study site ➢ Attend Sponsor audit and Regulatory Authority audit for different clinical trials ➢ Attend various investigator’s meeting global/local for protocol training and other study procedures Show less

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  Atos

  May 2017 - Jan 2022

  ETMF Lead

  ➢Maintaining TMF as per DIA reference model, industry best practices and regulatory requirements ➢ Managing overall document processing activities and handling team of more than 20 members for outsourced / In house trials – Metadata tagging, Artifact selection, TMF Import to different eTMF platforms, Quality check & Archive ➢ Managing Quality check team for performing technical and Content QC of TMF. Defining Quality checklist for TMF ➢ Collaborating with different CRO's/Clinical teams for outsourced trials - TMF transfers, TMF Quality, TMF tracking and traceability &TMF completeness check ➢ Supporting audits and Inspections. Defining and tracking key quality indicators and overall compliance to TMF process and regulations ➢ Defining migration strategy for TMF between different TMF platforms ➢ Training CRO's on TMF process. Defining mode of TMF transfers for CRO and publishing Quality metrics of CRO transferred TMF documents ➢ Develop and maintain TMF guideline documents/SOP's/Work Instructions ➢ Drive TMF transitions for in license projects and Acquisitions. Mapping of TMF as per DIA reference model. Document reconciliation and remediation for Mergers and Acquisitions Show less

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  Veeda Clinical Research Limited

  Feb 2022 - Aug 2022

  Clinical Manager-QC eTMF/EDC

  ➢ Provide support and guidance for Quality Management System activities including self-reporting deviations, root cause analysis and Corrective Action/Preventative Action plan development and evaluation ➢ Hosting system audit and implementation of Corrective and Preventive Actions ➢ Work closely with the Training department to have the relevant training needs addressed ➢ Provide support and mentorship for new hires and other team members ➢ Visited investigator site for TMF QC visit for audit readiness purpose. Show less

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  Cognizant

  Aug 2022 - now

  Life science - Product Management -Veeva Vault eTMF/CTMS