Vaibhav Murukate
Senior Clinical Process Associate
Mumbai
Summary
Seasoned clinical research professional boasting over 6 years of clinical trial expertise and 4 years of dedicated service within R&D Pharmaceutical industry. Renowned for seamlessly integrating with multicultural teams to deliver superior quality results and clear, open communication at all levels. Eager to contribute skills and experience to the team.
Overview
2025
2025
years of professional experience
9
9
years of post-secondary education
3
3
Languages
Work History
SENIOR CLINICAL PROCESS ASSOCIATE
IQVIA Ltd
6 2022 - Current
- Review the study files in eTMF and analyze the health status of TMF and reach out to sites for missing documents
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
- Maintenance of Wingspan completeness for the study, setting up the study by executing the wizard (study and country)
- Addition/deletion of required placeholdes as per study team request
- Review of the payment batches in CTMS for patient visits as well as for Adhoc payments against the Electronic Data Capture data, budget schedule in Clinical Trial Agreement (CTA) and applicable SOPs
- Assist with final payment reconciliation of Investigator payments on study closeout
- Perform QC and finalize redline and final CTA as per SOP/project specific guidelines and instructions
- Perform efficient reviews of Essential Document Packs and track status through CTMS to ensure timely site initiation.
- Ensure quality and compliance of site contracts, maintaining high standards and adherence to regulatory requirements
- Responsible for RWE Support mailbox management and work delegation
- Establish and maintain effective project/site communication
- Coordinate and collaborate with various project stake holders
- Assist with quarterly study user list task.
- Perform assigned administrative tasks to support project team members with clinical trial execution
SENIOR PROCESS ASSOCIATE
Tata Consultancy Services
Thane
05.2018 - 05.2022
- Responsible for handling Clinical Trial Documents and Activities as agreed with the Sponsor in alliance with the SOPs
- Supporting Trial Team to meet urgent deliverables ensuring inspection readiness
- Organizing Study Startup Meetings, ongoing study activities, management and archival activities at the end of study
- Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLA's) and within project timelines
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
- Participate in document management (review, maintenance, storage as applicable
- Uploading and promoting documents in RIMS
- Electronic site approval for IP/drug shipment through system
- Meeting project timelines and quality standards set up by internal client
- Monitoring and processing the email requests received in group mailboxes
R&D OFFICER, FERMENTATION DEPARTMENT
FDC Ltd
Mumbai
10.2015 - 05.2018
- Carry out routine experiments with fermenters
- Fermenter batch planning and execution
- Fermenter media preparation and media sterilization
- Seed inoculation and seed transfer
- Operate different utilities and Instruments/Equipments related with Fermenters
- Adhere to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)
JUNIOR RESEARCH ASSOCIATE
IPCA Laboratories
Mumbai
04.2014 - 09.2015
- Equipment preparation, maintenance of process parameters, sample analysis
- Development of experimental methods, techniques and process to define and improve microbial fermentation systems for pharmaceutical production
- Small scale fermentation development, media development, application of scientific/ engineering principles and techniques relevant to development of microbial cultures and fermentation.
Education
Master of Science - Biotechnology
Viva College
Thane, India 01.2011 - 04.2013
Bachelor of Science - Biotechnology
Mithibai College
Mumbai, India 01.2008 - 03.2011
Higher Secondary - Science
Ruia College
Mumbai, India 01.2006 - 04.2008
SSC -
Utkarsh Mandir
Mumbai, India 01.2005 - 02.2006
Skills
Trial Master File Activities
Regulatory Document Review
Teamwork and Collaboration
Software : Veeva Vault, CTMS, Wingspan, Medidata
Site Visit Report review and Site Payment activities
Regulatory Compliance
Administrative coordination
Microsoft Office toolkit
Timeline
SENIOR PROCESS ASSOCIATE
Tata Consultancy Services
05.2018 - 05.2022
R&D OFFICER, FERMENTATION DEPARTMENT
FDC Ltd
10.2015 - 05.2018
JUNIOR RESEARCH ASSOCIATE
IPCA Laboratories
04.2014 - 09.2015
Master of Science - Biotechnology
Viva College
01.2011 - 04.2013
Bachelor of Science - Biotechnology
Mithibai College
01.2008 - 03.2011
Higher Secondary - Science
Ruia College
01.2006 - 04.2008
SSC -
Utkarsh Mandir
01.2005 - 02.2006
SENIOR CLINICAL PROCESS ASSOCIATE
IQVIA Ltd
6 2022 - Current
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