Clinical Research Associate at Novartis – Mumbai, India
Job Summary:
Novartis Healthcare is hiring a skilled Clinical Research Associate (CRA) in Mumbai to oversee clinical trial operations, ensure regulatory compliance, and enhance site collaboration. This role demands expertise in Good Clinical Practice (GCP), patient data monitoring, and protocol adherence to uphold the integrity of clinical studies from Phase I to IV. Be part of a global pharmaceutical leader committed to transforming healthcare.
Key Responsibilities:
Serve as the primary liaison between Novartis and study sites, ensuring efficient collaboration.
Conduct Site Initiation Visits and ongoing site monitoring (on-site and remote).
Train and retrain site staff on protocol and regulatory updates.
Monitor adherence to ICH/GCP, Health Authority guidelines, IRB/EC, and data privacy requirements.
Identify and mitigate risks or deficiencies in site processes.
Collaborate with cross-functional teams (SSO CPM, CRA Manager, MSL, CRMA) to support optimal recruitment and data quality.
Ensure all documentation aligns with Good Documentation Practices (GDP) and Novartis standards.
Participate in audits and ensure inspection readiness at clinical sites.
Manage timely data query resolution and ensure Investigator Folder and sTMF(s) are updated.
Required Skills & Qualifications:
Degree in Scientific or Healthcare discipline (or equivalent healthcare experience).
Fluency in English and the local language.
Proficient knowledge of ICH-GCP guidelines, clinical trial monitoring, and regulatory requirements.
Strong interpersonal and communication skills to manage site relations.
Ability to train site staff on protocol amendments and trial procedures.
Desirable Skills:
Prior experience with Phase I-IV clinical trials.
Understanding of risk management and site process improvement techniques.
Perks & Benefits:
Full-time, stable employment with Novartis, a global leader in healthcare innovation.
Opportunities for professional development and upskilling.
Inclusive work environment focused on diversity and integrity.
Comprehensive benefits and rewards program (as per Novartis policies).
Access to Novartis’ global network and resources.
Company Description:
Novartis Healthcare Pvt. Ltd. is a global leader in pharmaceutical research and development, committed to addressing some of the world's most challenging healthcare issues. With a strong presence in India, Novartis focuses on transforming patient lives through science-driven innovation and ethical research practices.
Work Mode:
On-site – Mumbai (Head Office)
Call to Action:
If you are passionate about clinical research and want to contribute to breakthrough healthcare solutions, apply now to join Novartis and shape the future of medicine.
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