Clinical Study Associate (Senior Process Associate) & Trainer
Mitesh Patil
Tata Consultancy Services Ltd
Naigaon,Maharashtra
7
Years of experience
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.
Work History
4 Months
07.2026 - Current
4 Months
Clinical Study Associate (CSA) Trainer
Tata Consultancy Services Ltd | Thane
07.2026 - Current
- The Trainer is responsible and accountable for training and mentoring team members and ensuring their compliance with ICH-GCP, the role-specific training plan.
- For all associates, the trainer will ensure compliance to the Training plan (for onboarding and ongoing updates).
- Trainer will impart training of processes listed in Approved Training Plan and connect to subject matter experts and points of contact within the Sponsor organization where applicable and as required as per alignment with Sponsor stakeholders (for e.g. Sponsor process POCs).
- Maintain Training documents for associates in the team.
- Mentor all associates.
- Coach and counsel associates regarding their role and processes as needed.
- For all Associates, ensure compliance to ICH-GCP guidelines while performing all process-related activities.
- Escalate identified unresolved training-related issues to the immediate supervisor in a timely manner.
- Responsible for creating and maintaining process documentation.
- Analyze trends or patterns of issues and concerns and highlight to Team Lead and have mitigation plans in place.
- The Trainer might perform the role of an Associate as per process need.
- Trainer to screen and evaluate the new candidate trainer & provide feedback on the training sessions conducted.
- Trainer to certify a new candidate trainer.
6 Years 4 Months
07.2020 - Current
6 Years 4 Months
Clinical Study Associate
Tata Consultancy Services Ltd | Thane
07.2020 - Current
- Provide operational support to global Study Management Teams (SMTs) across study planning, start-up, conduct, and close-out.
- Ensure compliance with ICH-GCP, SOPs, and applicable regulations.
- Maintain study progress trackers, reports, and data accuracy.
- Coordinate with CROs, vendors, and Sponsor stakeholders.
- Track study deliverables, timelines, and pending activities.
- Maintain study documentation and Trial Master Files (TMF).
- Manage study touchpoint areas, document access, and filing.
- Grant, modify, and revoke access to Sponsor and vendor systems.
- Identify and escalate data quality, compliance, and operational issues.
- Contribute to process improvements, best practices, and standardized tools.
- Participate in study meetings and support study-specific activities.
- Prepare CSV documents, including BRD, Macro Compliance Assessment, Test Plan, Macro Test Cases, and Test Qualification Summary Report, if applicable.
9 Months
09.2019 - 06.2020
9 Months
eTMF Document Specialist
Tata Consultancy Services Ltd | Thane
09.2019 - 06.2020
- 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 Provide support during internal and external inspections by regulatory bodies.
1 Month
05.2018 - 06.2018
1 Month
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
Percentage: 60%
Higher Secondary Certificate (HSC) - Science
Maharashtra Board | Don Bosco Junior College, Naigaon | 07.2013 - 05.2015
Percentage: 56.5%
Secondary School Certificate (SSC)
Maharashtra Board | Karmaveer Bhaurao Patil Vidyalaya, Juchandra | 06.2007 - 06.2013
Percentage: 82.2%
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: Married
Awards
- Star of The Month Award, Jun 2021
- Star of The Month Award, Aug 2022
- Star of The Month Award, Jan 2024
- Star of The Month Award, Nov 2025
- 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 (CSA) Trainer
Tata Consultancy Services Ltd
07.2026 - CurrentRead more
Clinical Study Associate
Tata Consultancy Services Ltd
07.2020 - CurrentRead more
eTMF Document Specialist
Tata Consultancy Services Ltd
09.2019 - 06.2020Read more
Intern
Umang Pharmatech Pvt. Ltd.
05.2018 - 06.2018Read more
Mumbai University - Bachelor of Pharmacy, Pharmacy
07.2015 - 07.2019Read more
Maharashtra Board - Higher Secondary Certificate (HSC), Science
07.2013 - 05.2015Read more
Maharashtra Board - Secondary School Certificate (SSC),
06.2007 - 06.2013Read more