Prasad Devani Email & Phone Number

Regulatory Affairs Responsibilities:• Preparation of management status and timely updating of all regulatory requirements and status. • Liasoning with Indian FDA for GCT applications and import & export permissions.• Troubleshooting and time management skills. • Creating a backup data base and structured documentation control.• Preparation & Submission of the documents as per DCGI check listProject Management Responsibilities:• Allocate resources and coordinate with team of Monitors. • Review of project scope and project charter. • Manages and quality controls the execution of a clinical protocol for number of trials at multiple sites thus ensuring the successful progress and completion of the proposed study within the stipulated time lines. • Preparing Monitoring plan, assist in preparing project milestones and work breakdown structures. • Support to Project Managers on study related activities.Clinical Operations Responsibilities:• Efficiently perform study feasibility and PSSV: Selection of sites (Investigators) along with preparation of comprehensive feasibility report and PSSV reports. • Perform site initiation, monitoring and closeout visits as per Standard Operating Procedures & Good Clinical Practices. • Supervising the study team to conduct the clinical study at multiple sites in compliance with the protocol, sponsor and applicable regulatory requirements. • Actively perform submission of documents to Investigators for the purpose of Ethics Committee submission as per Ethics Committee Standard Operating Procedures. • Competently administer protocol, GCP & study related training to the site staff of assigned sites and keep regular communication with the site staff regarding on-going projects. • Ensure that the 100% Informed Consent Documentation is done in compliance ICH-GCP and applicable regulatory requirements.

Listed skills include Ich Gcp, Clinical Monitoring, Gcp, Cro, and 20 others.