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Sanket Rasal

eTMF Specialist | Veeva Vault | TMF Reference Model | ICH-GCP E6(R2/R3) | Clinical Trial Documentation | ALCOA+ | Inspection Readiness

Thane

1+ year of work experience

Tata Consultancy Services
May 20251 yr 2 mosPresent

A global leader in IT services, consulting, and business solutions supporting clients across various industries, including life sciences and clinical research Upload, review, and maintain essential clinical trial documents in the eTMF system(Veeva). Creating, updating, and deactivating user accounts in clinical systems (like eTMF, CTMS, or EDC) while ensuring correct access levels based on each user’s role. Perform QC checks to confirm documents are accurate, complete and compliant. Ensure tasks are completed within deadlines and according to standard operating procedures (SOPs). Maintain thorough and organized records of all project-related information for internal and external audits. Manage CTMS AND eTMF documentation ensuring compliance with GCP and inspection readiness. Collaborate with various internal department's. Ensuring alignment of all project activities with Good Clinical Practice (GCP) guidelines and regulatory requirements.. Perform discrepancy management in accordance with the process guidelines and timeliness.
Sep 20246 mosFeb 2025

A pharmacy providing quality healthcare services, medication dispensing, and patient counselling to ensure safe and effective treatment outcomes. Accurately dispensing prescribed medicines to patients. Check prescriptions for dosage, strength, and instructions before handing out medication. Maintain proper stock of medicines and medical supplies. Monitor expiry dates, Reorder low-stock items, and ensure proper storage conditions. Record prescriptions in the register or pharmacy software. Ensuring compliance with Drugs and Cosmetics Act and Pharmacy Council regulations. Help maintain documentation for inspections and audits.

Education

SAHYADRI SHIKSHAN SANSTHAS GOVINDRAO NIKAM COLLEGE OF PHARMACY, SAWARDE, RATNAGIRI

Bachelor's of Pharmacy, Pharmacy

SAHYADRI SHIKSHAN SANSTHAS GOVINDRAO NIKAM COLLEGE OF PHARMACY, SAWARDE, RATNAGIRI

20213 yrs2024
SAHYADRI SHIKSHAN SANSTHAS GOVINDRAO NIKAM COLLEGE OF PHARMACY, SAWARDE, RATNAGIRI

D pharmacy, Pharmacy

SAHYADRI SHIKSHAN SANSTHAS GOVINDRAO NIKAM COLLEGE OF PHARMACY, SAWARDE, RATNAGIRI

20182 yrs2020

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Headline

eTMF Specialist | Veeva Vault | TMF Reference Model | ICH-GCP E6(R2/R3) | Clinical Trial Documentation | ALCOA+ | Inspection Readiness

About

eTMF and CTMS Specialist with 1+ year at TCS supporting clinical trial documentation, Veeva Vault eTMF, and inspection readiness across GCP-compliant studies.

Location

Thane

Work experience

eTMF DOCUMENT SPECIALIST at Tata Consultancy Services, May 2025 - Present · 1 yr 2 mos, A global leader in IT services, consulting, and business solutions supporting clients across various industries, including life sciences and clinical research Upload, review, and maintain essential clinical trial documents in the eTMF system(Veeva). Creating, updating, and deactivating user accounts in clinical systems (like eTMF, CTMS, or EDC) while ensuring correct access levels based on each user’s role. Perform QC checks to confirm documents are accurate, complete and compliant. Ensure tasks are completed within deadlines and according to standard operating procedures (SOPs). Maintain thorough and organized records of all project-related information for internal and external audits. Manage CTMS AND eTMF documentation ensuring compliance with GCP and inspection readiness. Collaborate with various internal department's. Ensuring alignment of all project activities with Good Clinical Practice (GCP) guidelines and regulatory requirements.. Perform discrepancy management in accordance with the process guidelines and timeliness.

Pharmacy Assistant at Medical-Store, Sep 2024 - Feb 2025 · 6 mos, A pharmacy providing quality healthcare services, medication dispensing, and patient counselling to ensure safe and effective treatment outcomes. Accurately dispensing prescribed medicines to patients. Check prescriptions for dosage, strength, and instructions before handing out medication. Maintain proper stock of medicines and medical supplies. Monitor expiry dates, Reorder low-stock items, and ensure proper storage conditions. Record prescriptions in the register or pharmacy software. Ensuring compliance with Drugs and Cosmetics Act and Pharmacy Council regulations. Help maintain documentation for inspections and audits.

Education

Bachelor's of Pharmacy, Pharmacy, SAHYADRI SHIKSHAN SANSTHAS GOVINDRAO NIKAM COLLEGE OF PHARMACY, SAWARDE, RATNAGIRI

D pharmacy, Pharmacy, SAHYADRI SHIKSHAN SANSTHAS GOVINDRAO NIKAM COLLEGE OF PHARMACY, SAWARDE, RATNAGIRI

Sanket Rasal - eTMF DOCUMENT SPECIALIST in Thane | Tal