Satish Patil
Clinical Trial Support Specialist
Bengaluru
Summary
Clinical Trial Support Specialist with 2 years of experience in clinical trial operations, data management, and regulatory compliance. Skilled in EDC systems, CTMS, and eTMF, with a strong understanding of GCP, ICH, and FDA regulations."
Overview
6
6
years of professional experience
1
1
year of post-secondary education
Work History
Clinical Trail Support Specialist
Accenture
Bengaluru
04.2023 - Current
- Managed and maintained clinical trial data in client repository, eTMF, and other systems.
- Produced Appendix 1.3 and 1.5 and financial disclosure tables for CSR deliverables.
- Set up and managed site, contact, and account information in client repository.
- Performed site documentation reconciliation (1572, CV, FDF) and uploaded/distributed SUSAR reports.
- Conducted study partner background checks and created OSI Site Level Data Sheets.
- Reconciled drug shipment addresses and managed discrepancies in clinical trial management data.
- Managed Rave, RIVRS, TAO, and eTMF access for site and study users.
- Perform study partner background checks via visual compliance tools
- Manage discrepancies in clinical trial management data coming from CRO partner systems
- Resolved Global Directory issues and created new vendor personnel and organizations in CTMS.
- Brief knowledge on CDM activities of Startup, Conduct and closeout phases
- Startup: Theoretical knowledge on Startup activities like Database designing, CRF designing, Validation, UAT, Edit specifications
- Conduct: Hands on experience on data review and maintenance, data reconciliation between CTMS and eTMF, issue listing and resolution
- Theoretical knowledge on site and vendor reconciliation, documents required for site vendor reconciliation, generating listings, queries generated and addressing
- Closeout: Theoretical knowledge on freeze and lock activities along with archival process
Procurement Specialist
Practo
01.2022 - 12.2022
- Tracked purchase orders and followed up with vendors and carriers to support timely deliveries.
- Maintained up-to-date database of suppliers, vendors and contracts to support accurate recordkeeping.
- Researched and identified potential new suppliers to increase vendor base.
- Enhanced the accuracy of demand forecasting through data analysis, enabling better decision-making in the purchasing process.
- Ensured compliance with company policies and industry regulations during the procurement process to minimize risks.
Hospital Pharmacy Intern
Sagar Hospitals
Bengaluru
06.2018 - 07.2018
- Adhered to all hospital policies and procedures while maintaining a professional demeanor during interactions with patients, staff, and other healthcare providers.
- Interacted with healthcare professionals to support timely and proper processing of prescriptions.
- Utilized electronic medical records systems to maintain accurate documentation of patient information and prescription history.
- Monitored inventory levels and notified pharmacist of items requiring reorder.
- Participated in quality improvement initiatives within the hospital pharmacy setting, contributing to improved patient safety measures.
Education
Master of Science - Master of Pharmacy
Rajiv Gandhi University of Health Sciences
Bengaluru, India 10.2020 - 07.2021
Skills
Participation
- Attended National seminar sponsored by ICMR and DSU on Targeted cancer therapy and research - Advances and challenges.
- Attended scope in clinical research and associated domains organized by the Department of Pharmacy practice
Declaration
I hereby declare that the above given information is true and correct to the best of my knowledge
Timeline
Clinical Trail Support Specialist
Accenture
04.2023 - Current
Procurement Specialist
Practo
01.2022 - 12.2022
Master of Science - Master of Pharmacy
Rajiv Gandhi University of Health Sciences
10.2020 - 07.2021
Hospital Pharmacy Intern
Sagar Hospitals
06.2018 - 07.2018
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