Head, Global Central Monitoring
Novartis
Total des années d'expérience :13 years, 7 Mois
As Head of the GCM, I led global initiative of Central Monitoring and Adaptive Monitoring (Risk Based Monitoring) in Novartis. I created processes and systems and established organizational structure for successful implementation of the new model.
I led a team of Central Managers, Team Leads, Experts & Central Monitors. We monitored clinical data from all global novartis trials, identifying errors and discrepancies in real time, and implementing corrective measures on an ongoing basis.
I am managing a team of Medics/Pharma associates.
Besides managing drug safety of our company through prompt processing and reporting of Adverse Events to the Regulatory Health Authorities, I participate in management meetings, perform performance reviews, perform and review RCAs, organize workshops / seminars and have delivered presentations.
My responsibilities include, but is not limited to the following:
• Manage Case Processing Team: Ensure that all cases are processed meeting regulatory timelines and according to standard operating procedures; Tracking the progress of cases & monitoring workload of the safety assessors; Ensure random QC of cases to maintain quality standards as per SLAs.
• Manage the team that prepares Safety Update Reports
• Ensure high level of quality and timeliness
• Promote effective communication within the team
• Support the management to achieve goals and objectives
• Identify training needs and facilitate training of the staff as required & training of the new recruits
• Participate in Leadership meetings
• Prepare action plans for effective use of resources
Managing team for processing adverse event reporting, preparing aggregate reports, safety signals and risk management plans.
Managing a team of healthcare professionals for processing adverse event reports coming from legal department of our client in the US of America.
Conduct and coordinate clinical trial in a hospital, which included subject recruitment, randomization, drug administration, regular reviews, adverseevent monitoring, coorindating with the sponsor / ethics committee / principal investigator / subjects. Maintaining patients' files, prepare for audit and inspections.
I was in-charge of preventive cardiology clinic. My main area of interest is prevention of ischeamic heart diseases, through intervention by means of diet, exercise and medications. I also attended to out patient clinics for sports injuries.