AKANKSHA PATIL
Mumbai
Overview
1
1
Certification
5
5
years of professional experience
Work History
eTMF Document Management Specialist
Tata Consultancy Services (TCS)
Thane, Mumbai
05.2023 - 11.2025
- Managed and maintained electronic Trial Master Files (eTMF) for Phase I–IV clinical trials in alignment with ICH-GCP requirements and sponsor standard operating procedures (SOPs).
- Oversaw daily operations, maintaining strict adherence to quality standards and regulatory compliance.
- Performed document classification and quality control (QC) reviews to verify completeness, accuracy, and compliance of study documentation.
- Tracked and followed up on missing, incomplete, or inaccurate documents, ensuring alignment with TMF Plan and study milestones.
- Conducted audit-readiness checks on trial documents, confirming appropriate context and alignment with TMF standards.
- Compiled study documentation status information and delivered TMF-related updates and insights to stakeholders, enhancing transparency.
Internship
Neon Laboratories, Palghar MIDC
02.2021 - 03.2021
- Rotated through key functions to enhance understanding of pharmaceutical manufacturing processes and departmental workflows.
- Gained insight into pharmaceutical operations across production, quality assurance (QA), Quality control (QC), Microbiology, Packaging and dispatch.
- Participated in structured on-the-job training sessions with supervisors to acquire practical skills. with supervisors and team members to develop practical skills.
Education
Master of Pharmacy - Pharmacology
SVKM's Dr. Bhanuben Nanavati College of Pharmacy (Autonomous), University of Mumbai
01-2027
Bachelor of Pharmacy -
Ideal Institute of Pharmacy, University of Mumbai
01-2022
Skills
- Clinical systems and eTMF management: Veeva Vault Clinical, RIM, Clinergize, First Doc, CTMS
- Clinical research and regulatory knowledge: ICH-GCP E6 (R2 and R3), FDA guidelines, clinical trial documentation
- Technical skills: Advanced Excel, Power BI
- Pharmacology laboratory skills: Blood withdrawal, drug administration routes, Animal handling
Certification
- Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs/New Drug (Version 3.0) — IIT Madras through SWAYAM | NPTEL | Elite Certificate | Score: 92% - 2026
- Two-day Workshop and Hands-on Training on Techniques in Experimental Pharmacology — September 2026
- IPC Webinar Series on Gene Therapy Products and Cell-Based Therapy Products — August 2026
- ICH Good Clinical Practice E6 (R3) — August 2025
- Good Clinical Practice (GCP) — National Institute on Drug Abuse (NIDA) | 2024 | Expires 2027
- Excel Skills for Business Job Simulation — Forage | 2024
- Graduate Pharmacy Aptitude Test (GPAT) — NTA | 2023 | Score: 96%
- Design and Interpretation of Clinical Trials — Johns Hopkins University through Coursera | 2023
POSITION OF RESPONSIBILITY
- Placement Coordinator at SVKM's Dr Bhanuben Nanavati College of Pharmacy.
Accomplishments
- Star of the Month Award at Tata Consultancy Services- Jun 2025
Timeline
eTMF Document Management Specialist
Tata Consultancy Services (TCS)
05.2023 - 11.2025
Internship
Neon Laboratories, Palghar MIDC
02.2021 - 03.2021
Master of Pharmacy - Pharmacology
SVKM's Dr. Bhanuben Nanavati College of Pharmacy (Autonomous), University of Mumbai
Bachelor of Pharmacy -
Ideal Institute of Pharmacy, University of Mumbai