Vivek Pathak

Experience

• 

  GVN Medical Centre

  Nov 2011 - Jun 2012

  Clinical Research Coordinator

  Responsibilities:• Data collection and management, completion of source documents, CRFs or eCRF’s, registration and management of AEs, filing and archiving, managing monitoring visits, dealing with queries and ensure Site master file is up to date.• Recruitment and co-ordination of the trial subjects covering informed consent, screening and inclusion of the subjects adhering to safety and compliance issues.• Assistance in Site Audit performed by Sponsor and Monitor.• Regulatory and ethical submissions and procedures and communicating with relevant authorities.• Co-ordination and management of the clinical trial, communication with sponsor, CRA and Central Laboratory and IVRS team, visit coordination, sampling.• Responsible for Investigational Product storage according to the temperature specifications drug dispensing & completion of study drug accountability & reconciliation forms.• Assist with budgets and contracts of Site.• Accountable for completing the patient entry in EDC System .• Manging the IVRS/IWRS system to complete the Trial related activities.• Development of Site SOP. Show less

• 

  MakroCare Clinical Research Limited

  Jun 2012 - Jun 2013

  Clinical Trial Assistant

  Responsibilities • Conduct the Pre-Study (Qualification), Site Initiation, Interim and Close-Out monitoring visits along with CRA.• Ensure complete and thorough study drug accountability and reconciliation.• Manage site TMF contents & Work with sites to ensure communication requirements between site and IRB are adhered.• Coordination with Site and Sponsors.• Health Authority & Ethics committee dossier submission.• Study Budget & Payment tracking, Inventory distribution and tracking.• Quality Review of Study Documents and Project Files. • Assistance to project Manager & Clinical Research Associates.• Inventory Management and Vendor selection.• QC and uploading of Study Documents at e-Portal.• Assitance to Project manager during ISO & Sponsor Audit.• Patient Data Review. Show less

• 

  Novartis

  Jul 2013 - Jan 2024

  • Former Role Name - Clinical Documents Processing manager (Aug-2021 to Jul-2023)• Manage assigned portfolio of In-Licensing / Out-Licensing / Acquisition / Divestment Projects, collaborating with key stakeholders with CDGM teams, Development Informatics, Legal, Development Quality Assurance and Global Project Teams.• Lead and/or Contribute to the development of TMF Transition Plans and ensure the successful transitions of TMF (paper and electronic) documentation outside of Novartis in support of out-licensing and divestment projects, and into Novartis in support of in-licensing and acquisition projects.• Deputized as ad-Interim Integration Team lead (for Short period) .• Develop and maintain paper and electronic document processes & standards relating to BD&L projects and Out-licensing activities, in compliance with internal and external requirements & regulations; • Identifying & raising risks/trends/patterns relating to TMF, BD&L projects, Out licensing activities and work with key stakeholders to define and implement pragmatic remediation. • Executes vendor oversight plan, monitors service metrics and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues. • Subject Matter Expert on TMF transition related training materials, formal and informal processes and tracking tools for TMF transition oversight activities in collaboration with stakeholders• Identify and implement improvements to document management processes to improve quality of TMF integration activities. May act as business lead for innovation projects to enhance integration processes.• Supporting for inspections/audits, contributes to root cause analysis identification and creation/delivery of CAPAs.• Vendor Oversight for TMF Documents processing and documents migrations from Third Party/Former Sponsor/CRO.• Oversight of TMF Health & Risk Assessment activity for BD&L Projects. Show less • TMF SME for CDS relevant activities.• Business Ownership for the eTMF reconciliation Tool.• Driving the Process Improvement initiatives within the team.• Collecting Metrics and KPIs for the team to share with Leadership.• Supporting the CDS Lead for any ad-hoc activities and represent the group in multiple forums.• Oversight for extended Team (Vendor Management).• Acted as an Ad-Interim Line Manager.• Leading the Inspection Readiness Activities for any upcoming Audit/Inspections.• Building Strategies on TMF QC activities for In-Licensing Projects.• Taking on additional Initiatives within department and with cross functional collaboration. Show less • Manage Vendors and external colleagues to perform the assigned activities.• Collect the group metrics quarterly for leadership team.• Handling multiple TMF migration and making sure TMF Quality maintained and inspection ready.• Handling the internal TMF audit.• As a TMF TOC & Virtual TOC super user make TMF compliance awareness in the organization.• Trainer and mentor for new Joiners or junior colleagues and CDS group at Accenture.• Continous process improvement and new system integration.• Collect and verify the drug batch information received per patient for CSR appendix documentation for trials without IVR tracking.• Verify and coordinate with drug supply management at the global level for re-supply needs for all study drugs at the CPOs for trials without IVR tracking.• Collaborate with clinical team members, field monitors, and other study team personnel to resolve issues with missing, incomplete, misfiled documents.• Maintain CDS Sharepoint as appropriate (e.g., correct content and links).• Responsible to set up and maintain HQ Trial Master Files (TMF) and ensure files are complete for each study center according to Novartis SOPs and guidelines.• Responsible for FPP process & appendices preparation for the CSR completion.• Ensure correct eCTD file naming convention for reference finalization in document management systems (e.g. CREDI )• Troubleshoots problems and is a liaison between the CTMR and CREDI help desk.• Participated in Trial Mapping initiative for Clinical Process.• Supported on TMF Archival.• Ensures the completion of Trial Completion checklist.• CSR Appendices & TMF QC activity. Show less • Responsible to set up and maintain HQ Trial Master Files (TMF) and ensure files are complete for each study center according to Novartis SOPs and guidelines.• Interact with clinical team members, field monitors, and other study team personnel to resolve issues with missing, incomplete, misfiled documents.• Development of guidance documents for the different tasks.• Responsible for global study submission checklist.• Key contributor in Onboarding manual development and roll out.• CSR Appendices release for assigned projects. Show less

  • TMF Integration Oversight Manager

    Aug 2021 - Jan 2024

  • Expert Clinical Document Specialist

    Sept 2018 - Jul 2021

  • Sr. Clinical Research Specialist

    Apr 2016 - Aug 2018

  • Clinical Research Specialist

    Jul 2013 - Mar 2016
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  Bristol Myers Squibb

  Feb 2024 - now

  Line Manager-TMF Study Leads & Archive team