Pratik N Borkar
TMF Manager
Thane
Summary
I am a Clinical Trial associate with overall experience of around 7+ yrs in healthcare industry. Skilled in both the aspects - Clinical and Technical. Good in written and oral communication skills. Learning and improving skills is my primary objective. I have an exposure of leading and mentoring the team.
Overview
10
10
years of professional experience
3
3
Languages
Work History
TMF Manager
IQVIA
06.2023 - Current
- TMF Oversight & Communication: Act as the primary liaison with study teams to address and resolve TMF-related action items, ensuring completeness and compliance.
- Quality Reviews: Conduct frequent TMF reviews to maintain accuracy, timeliness, and regulatory readiness.
- Audit & Inspection Support: Provide TMF expertise during audits and inspections, ensuring documentation integrity and availability.
- eTMF Reconciliation: Perform regular reconciliation of eTMF documents to confirm completeness and alignment with study milestones.
- Process Improvements: Designed and implemented 10–20 automation solutions, including dashboards and macros, to streamline workflows and enhance visualization.
- Client Reporting: Developed multiple dashboards and reports in NCV to provide clear insights and performance tracking for clients.
Team Lead - (e-TMF)
TCS
11.2021 - Current
- Currently working as a Team Lead mentoring 15 members at present.
- Uploading, reviewing the documents in Veeva vault consisting of various phases in clinical trials.
- Handling and monitoring the Team with Daily activities and performing appraisal of associates.
- Connecting with the Client for Monthly and Quarterly Strategic meetings.
- Following up with the study team and CRAs regarding the documents for any discrepancies or resolving their queries
- Taking interviews and onboarding activities of new joinees along with the essential Trainings
Data Reviewer (e-TMF)
TCS
02.2020 - 11.2021
- Proficient in handling Veeva Vault and generating reports in the Vault.
- Preparing, monitoring and sending the TMF Monthly report to Clients which summarizes the status of documents uploaded in Veeva.
- Have handled various activities and challenges to streamline the process by generating TMF Index, Metrics, Risk Reports etc.
- Have worked on multiple automations for process improvement – Weekly Metrics Tracker, QC Rejection Tracker, Uploading Tracker, etc.
- Have prepared Risk Report to calculate the risk for EDL documents and present it to Client.
Sr. CLINICAL PROCESS ASSOC.
IQVIA
05.2017 - 02.2020
- Have worked on systems like CTMS, Veeva Vault, SAFRNs, Oracle-Inform, eCTS, etc.
- Assisting the PTL to provide the overall summary of the protocol by providing them Project Level Dashboard for their respective studies.
- As a CTA - In Start-up phase, supporting the Protocol Team Lead (PTL) in start-up activities.
- Following up for Action items with the respective CRAs.
- Tracking the subject, site, visit status and milestones in CTMS system.
- While working as I CTA I have done reviewing the Monitoring Visit log and entering the data in CTMS.
- I have worked on eTMF by preparing, handling, distributing, filing and archiving of clinical documentation and reports as per SOPs.
- Leading and handling the team with respect to training and assignments.
- I have also got a chance to prepare slides for RFI and RFP for multiple Sponsors.
JR. PHYSICIAN PARTNER
INVENTURUS KNOWLEDGE SOLUTIONS (IKS)
10.2015 - 04.2017
- Working in Texas Health care project for Clinical data management to maintain EHR of the patients.
- Capturing the impressions/interpretations from the reports of the patient and maintaining it in eDC system.
- Worked on Dashboards to provide the metrics and handling the escalations and working on RCAs.
- Achieved quite good experience under operation management.
Education
PGDM - Operation Management
WELINGKAR INSTITUTE OF MANAGEMENT
Mumbai, India01-2019
Bachelor's - Pharmacy
GAHLOT INSTITUTE OF PHARMACY
Navi Mumbai, India01-2015
Skills
Experienced with MS Excel
Effective communication
Effective team management
Interests
Cycling
Timeline
TMF Manager
IQVIA
06.2023 - Current
Team Lead - (e-TMF)
TCS
11.2021 - Current
Data Reviewer (e-TMF)
TCS
02.2020 - 11.2021
Sr. CLINICAL PROCESS ASSOC.
IQVIA
05.2017 - 02.2020
JR. PHYSICIAN PARTNER
INVENTURUS KNOWLEDGE SOLUTIONS (IKS)
10.2015 - 04.2017
Bachelor's - Pharmacy
GAHLOT INSTITUTE OF PHARMACY
PGDM - Operation Management
WELINGKAR INSTITUTE OF MANAGEMENT