Dharmendra C.

Background

About Dharmendra C.

Strategic Thinking. Operational Excellence. Relationship Building. Communication. Adaptability. The cumulative weight of my historical and ongoing involvement within the realm of clinical research is of paramount significance. Proficiencies in diverse competencies such as excellent communication skills, data analytics with tools such as advanced level excel, Power Business Intelligence, and Qlickview, building interpersonal positive relationship with team and partnered vendors, and proactive approach towards daily work which can be utilized for the potential project management for Biotechnology and Medical Devices companies. • Result-driven and meticulous clinical research professional with broad range of experience in planning, management, and execution of clinical trials. • Excellent understanding of ICH, FDA/EMA guidelines for clinical studies, including ICH E6 (GCP), Study Protocol requirements, Informed Consent requirements, IRB/IEC requirements, ADR/safety reporting requirements etc. • Knowledge of FDA regulations & requirements for Drug & Medical Device approval pathways like IND, NDA, BLA, IDE, 510k and PMA, including GMP and Quality System Regulations requirements.