Mr. Chikku A Joseph
A globally experienced clinical research professional with a Masters in Clinical Pharmacy whose progressive experience spanning over a period of thirteen years in various clinical research capacities has profound understanding of clinical research methodology and regulations with specific expertise in ANDA and NDA studies.
He is highly skilled in developing project plans and schedules with hands on experience in tracking projects and reporting on budget and project status, evaluating system solutions and preparing reports for safety monitoring committees. He has excellent understanding of project management methodologies empowering him to effectively lead a cross-functional team.
His major responsibilities include planning and managing all aspects of a clinical trial to evaluate the safety and effectiveness of bio-pharmaceuticals and medical devices, to support regulatory submissions or marketing claims, manage a team of CRAs and act as a liaison between the study sponsor and the clinical trial site. Other responsibilities include training of team members, evaluating staff performance and leading the resolution of issues with the clinical study.