Summary About the Role Site relationship management role to ensure sustainable trial execution at Site Performs on-site and remote monitoring activities related to initiation conduct and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH GCP local regulations and SOPs Proactive site performance management recruitment quality and early identification of real site needs and issues as the single best point of contact internally externally for all sites from issue management to risk identification Senior Clinical Research Associate is assigned to more complex trials and or to less experienced sites where applicable Associate takes on the responsibility as SME Subject Matter Expert as needed participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines and participates in multi-disciplinary teams locally and globally to evaluate and implement process improvements Key Responsibilities Frontline liaison between Novartis and sites to ensure successful collaboration meeting Novartis expectation on milestone and deliverables with true ownership mindset Manages assigned study sites conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures Performs Site Initiation Visit ensures site personnel is fully trained on all trial related aspects Performs continuous training for amendments and recent site personnel as required Re-trains site personnel as appropriate Conducts continuous site monitoring activities onsite and remote Implements site management activities to ensure compliance with protocol ICH GCP global and local regulation including Health Authorities IRB EC data privacy requirements global and local processes as applicable Documentation according to GDP and Novartis standards Identifies deficiencies in site processes and

📌 Senior Clinical Research Associate (Mumbai)
🏢 Novartis
📍 Mumbai