Mitesh Patil
Clinical Study Associate
Naigaon,Maharashtra
Summary
Experienced professional dedicated to supporting organizational growth and making an impact on the Pharmaceutical and Healthcare Industry. Committed to contributing to firm success and personal development, passionate about driving positive change and delivering exceptional results. Excited to collaborate with a forward thinking team and drive innovation in healthcare.
Overview
5
5
years of professional experience
Work History
Clinical Study Associate
Tata Consultancy Services Ltd
Thane
07.2020 - Current
- Responsible for providing operational support to multiple global study management teams (SMTs) through all phases of clinical study management (Plan, Start-up, Conduct and Close-out) in accordance with appropriate quality standards including ICH/GCP and applicable regulations.
- Building relationships with SMT, Country Affiliates, Vendors, CRAs and Third parties including CRO's.
- Review and maintain accurate study level progress information. Provide SMTs with high quality support on the consistent use of study specific systems (Clinical Vault [eTMF and CTMS], RAVE, G Suite, SIP, CIDM and reports).
- Ensure study specific data and information is effectively communicated across relevant vendors. Oversee data integrity and quality in CTMS and related/interface systems (RAVE/SIP and IxRS etc.). Advise on CTMS and all the integrated systems across the functionality including interfaces.
- Monitoring of vendor systems (IxRS, Central Lab, Imaging etc.) and follow up on issues resolution. Ensure all the site and country level data is complete in the trial systems.
- eTMF inspection readiness support - providing documents and information prior and during inspection. Support Study Sr.COL and COL during inspection.
- Creation and timely maintenance of the trackers and dashboards.
- Attend scheduled meetings with the country operations team and vendors.
- Resolve issues and queries raised by the Country COLs, CRAs and CROs.
- Provide training materials to the site staff related to the study.
- Arrange virtual meetings with Study COLs/Ops Team on a set frequency to discuss process improvement strategies, study milestones achieved, future goals and decisions to be taken.
- Supporting regulatory investigator packages - Follow up with missing FDF, 1572s and CV's required for Regulatory Investigator packages.
- Responsible for requesting Global Insurance and for renewal or updating of the same.
- Uploading of essential initial phase documents to the Monitor's training portal.
- Request/manage access and training to Sponsor systems and vendor tools. Provide site information
- to vendors to prioritize shipment of initial supplies including Lab-kits and other study materials.
- Make recommendations for improvements to the Study Sr.COL and COL
- Access management of Roche specific systems.
- Create, Upload and Classify study level global documents in Clinical Vault system.
- Manage and Resolve document Quality Issues in Clinical Vault system
- Extract customized reports from Clinical Vault eTMF for Inspection Readiness.
eTMF Document Specialist
Tata Consultancy Services Ltd
Thane
09.2019 - 06.2020
- Responsible for requesting Global Insurance and for renewal or updating of the same.
- Uploading of essential initial phase documents to the Monitor's training portal.
- Request/manage access and training to Sponsor systems and vendor tools. Provide site information to vendors to prioritize shipment of initial supplies including Lab-kits and other study materials.
- Make recommendations for improvements to the Study Sr.COL and COL.
- Access management of Roche specific systems.
- Create, Upload and Classify study level global documents in Clinical Vault system.
- Manage and Resolve document Quality Issues in Clinical Vault system.
- Extract customized reports from Clinical Vault eTMF for Inspection Readiness.
- Act as a document creator / QC'er / primary contact for all issues related to TMF processing and inspection readiness.
- Collaborates with the eTMF Team Lead to ensure Trial Master File (TMF) business needs are addressed in a proactive and timely manner.
- Delivers quality control measures and communication of relevant TMF issues/challenges to the senior eTMF document specialist as the first line. Followed by the eTMF Team Lead and eTMF Group Lead.
- Provide input into functional SOPs, guidelines, and system user guides as related to the accuracy and completeness of TMF.
- Perform discrepancy management in accordance with the process guidelines and timelines.
- Provide support during internal and external inspections by regulatory bodies.
Intern
Umang Pharmatech Pvt. Ltd.
Vasai, Maharashtra
05.2018 - 06.2018
- Company Overview: Umang Pharmatech Pvt. Ltd. is a specialist of Exfoliating Spheres, Specialty Particles, and Encapsulation solutions to give various visual effects into formulations, situated at Vasai (E).
- Worked as Intern for 01 month in R & D Department, Q.C. Department, Food Department and Production Department.
- Umang Pharmatech Pvt. Ltd. is a specialist of Exfoliating Spheres, Specialty Particles, and Encapsulation solutions to give various visual effects into formulations, situated at Vasai (E).
Education
Bachelor of Pharmacy - Pharmacy
Mumbai University
Viva Institute Of Pharmacy, Virar 07.2015 - 07.2019
Higher Secondary Certificate (HSC) - Science
Maharashtra Board
Don Bosco Junior College, Naigaon 07.2013 - 05.2015
Secondary School Certificate (SSC) -
Maharashtra Board
Karmaveer Bhaurao Patil Vidyalaya, Juchandra 06.2007 - 06.2013
Skills
- Computer skills across multiple applications
- Problem-solving abilities
- Customer service and satisfaction
- Accuracy and Attention to details
- Interpersonal relationships
- Collaborative and Teamwork
Languages
English
Hindi
Marathi
Extra-Curricular Activities
- Participated and Secured various Prizes in Street-plays at college and Inter-college level.
- Participated in National and State Level Poster Presentation Competitions.
- Participated in various Quiz, Model Making and Product Packaging Competitions.
- Participated in Blood Donation Camps and Awareness camps representing College.
- Worked on Student Research Project On Vitamin-C Encapsulating Beads with Olive Oil during Internship.
Personal Information
- Title: Clinical Study Associate
- Date of Birth: 26th October 1997
- Gender: Male
- Nationality: Indian
- Marital Status: Un-married
Awards
- Star of The Month Award, Jun 2021
- Star of The Month Award, Aug 2022
- Star of The Month Award, Jan 2024
- Service and Commitment Award, Sep 2022
- Service and Commitment Award, Sep 2024
Hobbies and Interests
- Travelling to new places
- Sketching
- Listening to music
- Learning new things
Disclaimer
I Hereby declare that the above written particulars are true and correct to the best of my knowledge and belief.
Timeline
Clinical Study Associate
Tata Consultancy Services Ltd
07.2020 - Current
eTMF Document Specialist
Tata Consultancy Services Ltd
09.2019 - 06.2020
Intern
Umang Pharmatech Pvt. Ltd.
05.2018 - 06.2018
Bachelor of Pharmacy - Pharmacy
Mumbai University
07.2015 - 07.2019
Higher Secondary Certificate (HSC) - Science
Maharashtra Board
07.2013 - 05.2015
Secondary School Certificate (SSC) -
Maharashtra Board
06.2007 - 06.2013
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