Summary
Overview
Work History
Education
Skills
Languages
Rotaract
Timeline
Generic
Ashwini  B R

Ashwini B R

Sr. Clinical Process Associate
Bengaluru,KA

Summary

Detail-oriented professional with expertise in project management and regulatory compliance. Over 5 years of experience in clinical research, successfully leading teams to meet project deadlines and budget constraints. Certified CTMS - CF Compliance Regional Champion. I have a strong academic background in MSc. in Microbiology. Proven ability to implement efficient tracking systems and communicate project status effectively to senior management.

Overview

5
5
years of professional experience

Work History

Sr. Clinical Process Associate

IQVIA
Bengaluru
01.2024 - Current

Executed complex processes to deliver high-quality outputs per service level agreements and project timelines.

Established effective communications across projects and sites to ensure alignment.

Created and updated project documentation for improved accessibility and accuracy.

Ensured precise completion of internal systems, databases, and tracking tools.

Served as subject matter expert for internal quality control and completed PCQ - Analyst role.

Reviewed and recommended modifications to enhance existing processes.

Contributed to document management through creation, review, maintenance, and storage activities.

Participated in study team meetings to implement action items and drive progress.

Sr. Site Activation Specialist

IQVIA
Bengaluru
05.2022 - 01.2023
  • Served as SPOC for site activation and maintenance activities, ensuring seamless operations.
  • Collaborated effectively with SAM, Project Management, and cross-functional departments to achieve objectives.
  • Reviewed and prepared site documents to ensure precision and completeness.
  • Updated internal systems and project plans with accurate, current information.
  • Distributed finalized documents to sites and internal teams promptly.
  • Informed team members upon document completion to maintain workflow continuity.
  • Tracked and followed up on document progress and approvals, guaranteeing timely submissions.

Regulatory and Start Up Coordinator

IQVIA
Bengaluru
01.2021 - 01.2022

Executed start-up and site activation activities in compliance with regulations and SOPs.

Distributed completed documents to sites and internal project teams.

Prepared and reviewed site regulatory documents for completeness and accuracy.

Maintained internal systems, databases, and tracking tools with project-specific information.

  • Reviewed site performance metrics, providing feedback to management.
  • Established project planning and timelines, implementing necessary contingency measures.
  • Informed team members upon completion of regulatory and contractual documents.
  • Tracked progress and ensured timely execution of regulatory documents and approvals.

Education

Master of Science - Microbiology

Oxford Collage of Science And Commerce
HSR Layout Bengaluru
06-2020

Bachelor of Science - Biotechnology

M S Ramaiah Collage of Arts Science & Commerce
Bengaluru
06-2018

Skills

  • Project management and site activation
  • Regulatory compliance and document preparation
  • Process and quality improvement
  • Data analysis and eTMF management
  • CTMS and Veeva Vault proficiency
  • Microsoft Office expertise

Languages

English
First Language
Hindi
Proficient (C2)
C2
Kannada
Proficient (C2)
C2
Telugu
Upper Intermediate (B2)
B2
Tamil
Upper Intermediate (B2)
B2

Rotaract

  • Part of non profitable NGO - Rotaract Club of Yelahanka. Servicing as an Joint Secretary for the year

Timeline

Sr. Clinical Process Associate

IQVIA
01.2024 - Current

Sr. Site Activation Specialist

IQVIA
05.2022 - 01.2023

Regulatory and Start Up Coordinator

IQVIA
01.2021 - 01.2022

Master of Science - Microbiology

Oxford Collage of Science And Commerce

Bachelor of Science - Biotechnology

M S Ramaiah Collage of Arts Science & Commerce
Ashwini B R Sr. Clinical Process Associate