Summary
Overview
Work History
Education
Skills
Personal Information
Activities
Certification
Languages
Timeline
Generic

ADITYA V. YADAV

Bengaluru

Summary

Dynamic Regulatory and Start-Up Specialist with proven expertise at IQVIA, adept at ICF development and ethics approvals. Recognized for exceptional attention to detail and proactive stakeholder management, ensuring timely submissions and compliance. Committed to enhancing project outcomes through effective communication and adaptability in fast-paced environments.

Overview

5
5
years of professional experience
1
1
Certification

Work History

REGULATORY AND START-UP SPECIALIST 1

IQVIA
BENGALURU
03.2025 - Current
  • Creation of a study document list based on required documents needed for the study.
  • Prepare and build Country Study Start-up Packages.
  • Prepare and build electronic packages within our system for sites, which may include essential documents, and regulatory documents.
  • Track queries issued by regulatory bodies within the regulatory information management platform.
  • Create an ICF template based on the country's requirements.
  • Submission of amendments (e.g., Protocol and IB to local and central IRB, including ICF customization and amendments as required) for sites in the U.S. and Canada.
  • ICF customization and amendments to align with protocol and IB changes, ensuring full approval by IRB/IEC.
  • Translation of fully approved ICFs into local languages, as requested for specific sites.
  • Review essential documents against the checklist, as per country regulations.
  • Completion of any other defined transactional activities, i.e., Clinical Study Report (CSR) and Trial Master File oversight.
  • Under general supervision, serve as a Single Point of Contact (SPOC) in assigned studies for investigative sites, the Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures, work instructions, quality of designated deliverables, and project timelines.
  • Perform start-up and site activation activities according to applicable regulations, SPOs, and work instructions. Distribute completed documents to the site and internal project team members.
  • Prepare site regulatory documents and review for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
  • Review, track, and follow up on the progress, approval, and execution of documents, regulatory, ethics, informed consent form (ICF), and investigator pack (IP) release documents, in line with project timelines.
  • Provide local expertise to SAMS and the project team during the initial and ongoing project timeline planning.
  • Perform quality control of the documents provided by the sites.
  • May have direct contact with sponsors on specific initiatives.

Study Start-up Associate 1

ICON PLC
Bengaluru
09.2023 - Current
  • Ethics Committee (EC), Institutional Review board (IRB) and Competent authority submission and approval of Amendments.
  • Maintenance phase submission and approval of protocol, Investigator Brochure, Patient materials and other subject recruitment materials to IRB/IEC for US country.
  • Collect, review organize and assemble regulatory initial start-up and maintenance submission packages to Central IRB/IEC, Local EC/IRB, Competent authorities, any other local regulatory authorities as required by countries and in accordance with ICG/GCP and applicable country regulations.
  • Interact with Ethics committee, IRB to obtain necessary authorizations/approvals pertaining to clinical trial conduct (start-up and maintenance as assigned)
  • Forecast submission/approval timelines and ensure they are achieved, provide contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified.
  • Collect, prepare, review, approve, process and track regulatory and site level critical documents as required for study site activation in accordance with applicable country regulations/guidelines and principles of ICH/GCP.
  • Track the submission and approval strategies into relevant tracking system along with eTMF uploads of documents and relevant handover of sites to clinical team.
  • Update the ICF tracking log with current versions of ICF implemented at sites.
  • Expertise in eTMF systems including Wingspan and Veeva Vault for ensuring completeness and quality of Essential documents.

Clinical Document Management Associate

Novotech
Bengaluru
05.2022 - 09.2023
  • Set up, receive, track, and maintain electronic or paper TMFs according to the requirements of ICH GCP and Novotech (or client) SOPs
  • Use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked, and filed according to Novotech (or Clients) SOPs
  • Provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner
  • Ensure the TMF is always ‘inspection ready’ and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines
  • Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance
  • Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project
  • Runs monthly reports to ensure accuracy of the files by performing file reviews
  • Prepares the TMF for delivery at study closeout straightforward documents
  • Reviews and prepares the TMF for audits and TMF reviews; Provide support to TMF Operations during audits and/or regulatory inspections
  • Experience in working on different TMF including WingSpan, Veeva Vault, Sure Clinical and Montrium

Centralized Regulatory and Start-Up Coordinator

IQVIA
Mumbai
01.2021 - 05.2022
  • Performs regulatory, start-up and maintenance activities in accordance with regulations, SOPs, and project requirements either at global, regional, or country level
  • Prepare client deliverable documents using approach tools and draft text for straightforward documents
  • Completion of relevant Clinical Trial Management System (CTMS) fields, databases, tracking tools, timelines, and project plan with project specific information
  • Working on handling the documents such as CTA, Budgets, LOI’s and Tax documents
  • Prepares and manages site regulatory documentation, collects and reviews essential documents according to sponsor requirements, supports for IRB submission, maintains, reviews and reports on site performance metrics, tracks completion of regulatory submission and documents TMF filing on established project timelines
  • Perform on process such as Contract uploads, Site ready to enroll forms, EDP reviews, Submission and Approval of IRB documents, TMF Filing, CTMS Data entry and Clinical Handovers

Education

POST GRADUATE DIPLOMA - CLINICAL RESEARCH

ICBIO INSTITUE
12.2020

BACHELOR OF SCIENCE - BIOCHEMISTRY

RUIA AUTONOMOUS COLLEGE
01.2020

Skills

  • Adobe Acrobat
  • PDF 24
  • Microsoft Operating system
  • Communication skills
  • Interpersonal skills
  • Stakeholder management
  • Prioritization
  • Adaptability
  • Attention to detail
  • Proactivity
  • Ethics approvals
  • ICF development

Personal Information

Date of birth: 06/Nov/1999

Activities

  • Passed fundamental GCP accreditation Exam, 02/01/21
  • Earned “C” grade in Elementary and Intermediate grade drawing examination

Certification

  • Passed the fundamental GCP accreditation exam on 01/21/2021

Languages

Marathi
First Language
English
Proficient (C2)
C2
Hindi
Advanced (C1)
C1

Timeline

REGULATORY AND START-UP SPECIALIST 1

IQVIA
03.2025 - Current

Study Start-up Associate 1

ICON PLC
09.2023 - Current

Clinical Document Management Associate

Novotech
05.2022 - 09.2023

Centralized Regulatory and Start-Up Coordinator

IQVIA
01.2021 - 05.2022

POST GRADUATE DIPLOMA - CLINICAL RESEARCH

ICBIO INSTITUE

BACHELOR OF SCIENCE - BIOCHEMISTRY

RUIA AUTONOMOUS COLLEGE

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ADITYA V. YADAV