Abhishek Shahane

• Responsible for Site Initiation, Interim Monitoring and Site Closeout.
• Monitor IP Packaging, Labeling Dispensing and dosing.
• Assist in the preparation and maintenance of essential trial documents, including protocols, Informed consent forms, case report forms, and study manuals
• Collaborate with cross functional teams to initiate clinical trial sites, including the preparation And distribution of study supplies to investigative sites
• Support the development and implementation of clinical trial tracking systems and databases
• Coordinate with clinical investigators and site personnel to ensure proper training and Adherence to study protocols, regulations, and guidelines
• Assist in the review and verification of clinical data and source documentation for accuracy And completeness
• Facilitate communication between study sites and the clinical operations team, addressing Inquiries and resolving issues in a timely manner
• Participate in the planning and execution of site initiat