G S Nihal

Results driven towards passion for clinical research development. Proven ability to analyze and interpret complex scientific data, coupled with excellent problem-solving skills committed to enhance patient care through the discovery of innovative drugs and therapies. Seeking opportunities to contribute my knowledge and skills in a research setting.

Project support coordinator (eTMF Support coordinator) - PPD - Bengaluru

(2025-05)

• Collaborates with project leads and staff to collect and retain study documents, ensuring their completeness and compliance.
• Performs quality checks, files documents in PPD's eTMF at study, country, and site levels and promotes documents to a status of "Approved".
• Classifies and indexes eTMF documentation with accurate metadata according to department standards
• Identifies and records quality issues, communicating with colleagues globally regarding errors in documents, providing solutions and resolving issues, as appropriate
• Compiles and distributes eTMF metrics reports to Project Leads and team members for assigned studies and follows up on issues noted
• Provides systems (e.g., CTMS, SharePoint & eTMF) support by managing access requests within the centralized filing support team
• Files documents in client eTMFs as specified by a study's eTMF plan
• Additionally, conduct the site feasibility study filing and transmit the report to the feasibility study team.

Document Specialist - (eTMF Specialist) - IQVIA - Bengaluru, India

(2023-11 - 2025-04)

• Reviewing and indexing essential documents within the Veeva vault software in accordance with the master list provided by the sponsors.
• Classify all essential documents efficiently according to the relevant Standard Operating Procedure, Country regulations, and industry best practices. Maintain detailed logs and indexes to track the documents and provide regular status updates.
• Complet the assigned tasks as scope of work like Reclassification documents and updation of metadata.
• Execute designated Quality Checks (QC) on imperative clinical documents in accordance with standardized procedures.

Intern - Stelis Biopharma Pvt.Ltd - Bengaluru

(2021-09 - 2021-10)

M Pharm - Pharmacology - Ramaiah University of Applied Sciences (2021-08 - 2023-07)

B Pharma - KLE College of Pharmacy (2017-08 - 2021-09)

PUC - 11th & 12th - Sri Chaitanya Sai Bharathi Jr. college (2015-06 - 2017-04)

10th - SSC - Sri Chaitanya Techno School (2014-04)