Dinesh Rajamanickam
Group Leader @ICON plc
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WORK HISTORY
Group Leader @ICON plc
Bengaluru, IN
Manage a team of 15+ specialists to handle due diligence activities & 5+ study start associates/assistants to handle study milestone & submission logging activities on CTMS including eTMF filing.• Line management of dedicated team of Study Start up Associates & Due Diligence Specialists.• Ensure team compliance with company\'s systems and procedures.• Regularly monitor and manage team/staff workload to optimize resource utilization.• Effectively monitor and manage team/staff performance as well as perform interim/annual performance appraisal by setting clear goals and objectives for team and individuals.• Ensure all work performed by teams is of high quality, compliant with GCP, ICH guidelines and all applicable laws and regulations.• Ensure team delivers to study as defined by protocol & per agreed timelines & budget set.• Ensure team collects, reviews, approves, tracks regulatory & site level essential documents for site activation.• Prepare SOPs, WP & Training modules as per client requisite and implement processes to team.• Represent clinical operations in sponsor and internal audits.• Responsible for recognizing need and creates process improvement within team.• Active participation in reviewing & negotiating CTA/Budgets with assigned Study Team/Sites.• Perform data analysis & metrics to senior management for all Study/Sponsors requisite.• Develop process automation using advanced VB scripts in MS Excel for department level benefits
EDUCATION
MVJ College of Engineering, Bangalore, India
Bachelor of Engineering - BE, Biotechnology
ABOUT DINESH RAJAMANICKAM
As a Study Start Up Group Leader at ICON plc, I manage a team of 15+ specialists to handle due diligence activities and 5+ study start associates to handle study milestone and submission logging activities on CTMS including eTMF filing. I have more than 12 years of experience in the clinical research industry, with a background in biotechnology engineering and software development/testing.I am passionate about delivering high-quality, compliant, and timely study start up and due diligence services to our clients, while optimizing resource utilization, team performance, and process improvement. I have successfully recruited, supervised, and led teams of 20+ specialists in two locations, developed and initiated a team of 7+ SSUAs for data logging activities, and prepared SOPs, WPs, and training modules as per client requirements. I have also contributed to the negotiation of CTAs and budgets, the collection, review, and approval of essential documents, and the development of VB macros in MS Excel to automate processes.
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