Study Start-Up Clinical Research Associate (SSU CRA)
Location: Mumbai, India | Company: Novartis Healthcare Pvt. Ltd.
Experience Required: Minimum 3 years in clinical research/site monitoring
Work Mode: Hybrid | Job Type: Full-time
Job Summary:
Join Novartis as a Study Start-Up Clinical Research Associate and play a pivotal role in initiating Phase I–IV clinical trials. This role bridges regulatory, operational, and site-level activities to ensure smooth and compliant site activation. Ideal for experienced clinical professionals with a passion for patient-centric research and site collaboration.
Key Responsibilities:
Lead end-to-end start-up processes from country allocation to site greenlight
Act as the primary liaison with clinical sites during start-up
Prepare and manage submissions to IRBs/IECs and health authorities
Ensure complete and timely collection of site documents (e.g., CVs, GCP certificates)
Coordinate contract negotiation, vendor setup, and financial discussions with sites
Maintain Trial Master File (TMF) and clinical systems up to audit readiness
Collaborate with global and internal stakeholders for smooth site handover
Support audit readiness and inspection preparedness for assigned sites
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences, Pharmacy, or related healthcare field
Minimum 3 years’ experience in clinical research/site monitoring/start-up
In-depth understanding of ICH-GCP guidelines and regulatory processes
Strong organizational and multi-tasking capabilities
Proficient in stakeholder and site communication
Ability and willingness to travel for site visits and meetings
Detail-oriented with a compliance-first approach
Perks & Benefits:
Competitive salary package and performance bonuses
Hybrid work flexibility with a collaborative global team
Comprehensive health & wellness benefits
Career growth and internal mobility across Novartis divisions
Access to Novartis Life Handbook: Explore Benefits
Company Overview:
Novartis is a global leader in pharmaceutical innovation and drug development. With a mission to reimagine medicine, Novartis delivers transformative treatment solutions that serve millions of patients worldwide. In India, Novartis supports cutting-edge research and clinical operations from its Mumbai and Hyderabad locations.
Work Mode:
Hybrid – Mumbai, India
Call to Action:
Are you ready to accelerate clinical trial activation in a global pharmaceutical leader? Apply now and be a catalyst in shaping the future of medicine with Novartis.
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