Summary
Overview
Work History
Education
Skills
Websites
Certification
Communication Skills
Leadership Experience
Awards
Timeline
CustomerServiceRepresentative
VISHAL GHODEKAR

VISHAL GHODEKAR

Clinical study specialist
Pune,MH

Summary

A professional in the field of clinical Research and Clinical Operations with overall 4 years of experience on working on various clinical trials i.e., Covid Trials (Mild and Moderate), Immunization trial (Covid and Chikungunya) and an Ophthalmic trial for Wet-AMD on pediatric population. Additionally played role of Single point of contact (SPOC), Team member, Trainer. Experience working with global study teams like CSM, GSM. Good communication skill ability to build effective relationships with colleagues & well organizational, IT and administrative skills.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Clinical Study Specialist

07.2024 - Current
  • Role includes coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
  • Proactively communicates any risks to project leads. Supports the maintenance of study specific documentation and systems including but not limited to study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
  • Provides system support (i.e. GoBalto & eTMF).
  • Supports RBM activities. Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
  • Supports scheduling of client and/or internal meetings. Reviews and tracks local regulatory documents.
  • Transmits documents to client and centralized IRB/IEC.
  • Analyzes and reconciles study metrics and findings reports.
  • Assists with clarification and resolution of findings related to site documentation. Maintains vendor trackers.
  • Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  • Assists with study-specific translation materials and translation QC upon request.

Process Associate (Clinical Operations Associate)

TATA CONSULTANCY SERVICES LTD.
Thane, Maharashtra
11.2022 - 06.2024
  • Playing a role of Single point of contact (SPOC) who is responsible for direct communication with client. Keeping the client's expectations in mind and get the work done by the team mates with quality.
  • Hands on experience on major clinical trial systems (CTMS, I Medidata RAVE, Veeva Quality, Veeva Quality Docs, Veeva Clinical, Shared Investigator Platform & e-Trial Master File, etc., which are used daily in clinical operations to perform various study activities in clinical trials.
  • Have an experience of CTMS data entry and access management for various tools/systems.
  • Handling access management for various application like QuORUM, CTMS, PD103.
  • Worked on IxRS for addition of visit dated for study participants.
  • Trainer for CTMS Access Management and Assignments in CTMS.
  • Hands on experience of workspace creation and G-form creation for Site Feasibility Questioner.
  • Providing support for CTMS for various queries faced by study team.
  • Keeping process guidelines, SOP's & flowcharts up to date for audit compliance.
  • Point of contact for process related queries and concerns for teammates, team leads, group lead, study teams and clients as well.
  • Additionally, managing cultural events and fun activities (On floor as well as Virtual) to boost team's energy which gives better working outcomes.
  • Collaborated with team members for enhanced process efficiency and productivity.
  • Handled high volumes of incoming work requests professionally while maintaining excellent organization.
  • Communicated effectively with colleagues and supervisors to resolve issues promptly and accurately.
  • Managed multiple tasks simultaneously, ensuring timely completion of all assignments.

Clinical Research Coordinator

Clinithink Services
Pune, Maharashtra
07.2021 - 05.2022
  • Involved in on-site phase-3 clinical research operations as a Clinical Research Coordinator which includes below mentioned activities.
  • Leading Ophthalmic Clinical Trial of indication Wet AMD on pediatric patients.
  • Thorough understating on Protocol.
  • Coordinating with principal investigators in obtaining the Informed Consent Forms (ICFs) from subjects and maintaining the same.
  • Subject screening - Assessing the inclusion and exclusion criteria.
  • Executing the Randomization procedure.
  • Source documentation.
  • E-CRF entry (Medidata RAVE, CTMS).
  • Resolving the Data Management queries.
  • Liaising with CRAs, Study Investigators and IRB/EC.
  • Follow-up on subject visits, coordinating with phlebotomists at on site.
  • Maintaining Trial Master File (Including site feasibility, PI details, IB, Protocol, ICFs, Drug accountability, Inventory log, EC, CRA and correspondences.
  • Assisting in trial monitoring and auditing visits.
  • SAE Reporting.

Education

Bachelor of Pharmacy - undefined

Parikrama College of Pharmacy
08.2022

Skills

  • People Management
  • Teamwork
  • Customer Centric
  • Leadership
  • Time Management
  • Proactive
  • Growth Oriented
  • Multitasking
  • Attention to details
  • Google Suit
  • MS Office

Certification

  • Good Clinical Practice, 2021-07-01, NIDA Clinical Trials Network
  • Novel Drug Delivery System, 2022-01-01, Published in IJCRT
  • Advanced Clinical Research Certification Course, 2022-01-01

Communication Skills

  • Assisting group lead/team lead for drafting important emails for client.
  • Training new associates.
  • Communicating with clients regarding their expectations.
  • Guiding study participants throughout the trial.
  • Communicating with monitors, project leads regarding Audits, monitoring visits.

Leadership Experience

  • Led the Ophthalmic study handled on pediatric population from startup to conduct phase at site level.
  • Class Representative for consecutive 3 years while leading to arrangement of cultural event, Industrial visit, institute level Quiz competition.

Awards

  • Best Study Coordinator appreciation received from Sponsor.
  • Appreciation received for working in Covid Trial during critical conditions.
  • Received appreciation in annual cultural event for best organizer for events and industrial visit.

Timeline

Clinical Study Specialist

07.2024 - Current

Process Associate (Clinical Operations Associate)

TATA CONSULTANCY SERVICES LTD.
11.2022 - 06.2024

Clinical Research Coordinator

Clinithink Services
07.2021 - 05.2022

Bachelor of Pharmacy - undefined

Parikrama College of Pharmacy

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VISHAL GHODEKARClinical study specialist