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Study Start-Up Clinical Research Associate

3+ years
Not Disclosed
10 July 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.