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, India
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
Bengaluru, India (Remote)
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, India (Remote)
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
Clinical Trial Management Systems (CTMS)
Electronic Data Capture (EDC) systems
Electronic Trial Master File (eTMF) systems (eg, Veeva Vault, TransPerfect Trial Interactive)
Microsoft Office (Word, Excel, PowerPoint, Outlook)
Data visualization tools (eg, Tableau, Power BI)
Well versed in Good Clinical Practice (GCP) training/ICH
Ability to work independently and as part of a team
Ability to adapt to changing priorities and deadlines
Strong problem-solving and analytical skills
Ability to maintain confidentiality and handle sensitive information
Strong organizational and time management 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