Vikas Devkar Email & Phone Number

Pune, Maharashtra, India

Pune, Maharashtra, India

Proficient in creating Standard Operating Procedures (SOPs) that ensure standardized processes and adherence to regulatory requirements.Actively engaged in monitoring and overseeing clinical trial sites, ensuring protocol compliance, data accuracy, and timely issue resolution.Adept at maintaining clear and productive communication channels with sites, vendors, and internal study teams, facilitating seamless collaboration and problem-solving.Diligently conducted Source Data Verification (SDV) to maintain data accuracy, integrity, and compliance with Good Clinical Practice (GCP) standards.Demonstrated a track record of meeting and exceeding recruitment targets, employing innovative strategies to identify and engage study participants.

Pune, Maharashtra, India

Orchestrated the timely submission of essential study-related documents to Ethics Committees (EC) and actively managed related activities to ensure regulatory compliance.Spearheaded the collection and maintenance of critical documents for in-house filing, guaranteeing seamless access to essential study records.Collaborated with the study team to support planning and logistics for study meetings, ensuring efficient coordination of all stakeholders.Maintained rigorous oversight of the Trial Master File (TMF) to ensure completeness and accuracy, facilitating efficient audits and inspections. Assisted in the management of site payments, ensuring accurate and timely disbursement to sites, which fostered positive relationships with investigators.

India