Hemanth Peetambaran

WORK HISTORY

EDUCATION

ABOUT HEMANTH PEETAMBARAN

A qualified Clinical Research professional with 15+ years of experience in core clinical operations. A positive, self-motivated, and goal-oriented professional with a proven track record of handling huge teams and processes across high complexity clinical trials ensuring high-quality deliverables at all times as per process requirements.Well versed in clinical operations and clinical project management as per ICH-GCP including stakeholder management consisting of Sponsors, vendors, CROs, regulatory authorities, and sites using cross-functional teams consisting of Medical, Project leadership, CRAs, CTAs, Data management, Data analytics, Medical data review teams, Site management, Budgeting and finance on global clinical trials conducted across various countries in tune with the local regulatory requirements.An innovative thinker with a proven ability to utilize the available resources to their best possible capacity to generate the required output within the given timelines specifically in the complex atmosphere of global clinical trials involving multicultural teams. Also functioned as an SME and Mentor supporting various training and development initiatives at the company and departmental level.Responsibilities• Working as a clinical project manager for Lilly leading, managing and coordinating with stakeholders, crossfunctional teams and third party organisations• Worked as Clinical Lead leading CRA and CTA teams based out of various countries on global studies in conduct phase while collaborating with multiple stakeholders which included internal teams, vendors, Sponsors, Regulatory authorities, and sites • Responsible for developing all study documentation including SOPs, notes to files, and training material for assigned activities as per projwct deliverables• Worked as a global CML leading the centralized monitoring team across various heirarchies on a Global studiesExpertiseClinical Trials Management, Clinical Research Management, Clinical Operations Management, Project Management, Project Planning, ICH & GCP Regulations, Onsite, and remote monitoring, Vendor Management, Regulatory Authority Coordination, Site Management, CRA and CTA team Lead, Centralized Monitoring team Lead, Country Clinical Operations Lead, R&D Management, CRA Training ManagementTherapeutic Areas:Neurology, Cardiovascular, Coronary Artery Stenosis, Gastrointestinal, Crohn\'s Disease, Ulcerative Colitis, COVID-19, Celiac Disease