Bhushan Nikam

Tmf Specialist @Indero (formerly Innovaderm)

Montreal, QC, CA

Participating in the development of the TMF structure and the eTMF Management Plan- Collaborating with the Project Coordinator to define project scope and develop the expected documents list (EDL) in the TMF- Managing multiple studies from initiation to completion, ensuring seamless execution and compliance- Conducting monthly focus meetings with the study team to discuss study metrics, ensure progress, and address issues- Performing completeness reviews to ensure all required TMF documents are accurate and filed as per regulatory standards- Conducting quality reviews to verify the accuracy, consistency, and compliance of TMF documents for inspection readiness- Uploading or importing documents into the TMF and assigning metadata- Resolving TMF-related issues and following up with action owners for open TMF issues- Attending internal or external study team meetings as required- Acting as a backup for team members when needed, while efficiently managing assigned studies- Performing administrative duties as assigned by management- Ensuring flexibility and proactive, responsible solutions to meet client satisfaction.

Sandip Foundation's Sandip Institute of Pharmaceutical Sciences, Mahirvani, Trimbak road, Taluka & District - Nashik 422213.

Batchelor of Pharmacy, B.pharmacy