Summary
At any given time, over 100,000 patients are participating in Novartis' clinical trials. The Global Clinical Operations (GCO) team at Novartis is dedicated to enabling faster trial recruitment and delivery, ensuring patients gain timely access to potential novel treatments. This pivotal role bridges the gap between science and medicine, allowing for a significant impact on patient care.
About the Role
Job Purpose:
The Senior Clinical Research Associate (sCRA) plays a crucial role in site relationship management, ensuring the sustainable execution of clinical trials. The sCRA is responsible for on-site and remote monitoring activities for Phase I-IV GDD trials, adhering to ICH/GCP guidelines, local regulations, and SOPs. This role involves proactive site performance management, addressing site needs, and acting as the main contact for all site-related issues and risks.
Key Responsibilities:
Site Management and Monitoring: Manage assigned study sites, conducting trials according to the Monitoring Plan and Novartis procedures. Perform Site Initiation Visits, train site personnel, and conduct continuous monitoring activities to ensure compliance with all relevant standards and regulations.
Process Improvement and Compliance: Identify deficiencies in site processes, work with sites to implement improvements, and promote a culture of compliance. Ensure human subject protection and the reliability of trial results.
Collaboration and Communication: Establish strong partnerships with sites to optimize patient recruitment and site performance. Collaborate with internal stakeholders, including the SSO Clinical Project Manager, CRA Manager, MSL, CRMA, and medical advisor, to enhance study outcomes and data quality.
Documentation and Audit Readiness: Maintain accurate and up-to-date site documentation, including the Investigator Folder and sTMF(s). Participate in audit and inspection readiness activities, implementing corrective actions as needed.
Training and Mentorship: Provide continuous training for site personnel, including new site staff and re-training as necessary. Mentor associates and share best practices to ensure high standards of site management.
Data Quality and Risk Management: Oversee the data query resolution process, ensuring timely and accurate data entry. Monitor and report site performance, escalating risks and issues as appropriate.
Qualifications:
Why Novartis?
Novartis is driven by a mission to reimagine medicine, improving and extending lives worldwide. Our vision is to become the most valued and trusted medicines company globally, a goal we pursue through the dedication and innovation of our associates. Join us in this mission and help shape a brighter future.
Commitment to Diversity & Inclusion:
Novartis is committed to building an inclusive and diverse workplace that reflects the communities we serve.
Benefits and Rewards:
For more information about the benefits and rewards offered at Novartis, please refer to the Novartis Life Handbook.
Join our Novartis Network:
If this role doesn't align with your experience or career goals, consider joining our Novartis Network to stay informed about future opportunities.
Location: Delhi, India
Division: Development
Business Unit: Innovative Medicines
Company / Legal Entity: Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time, Regular
Shift Work: No
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Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
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Najran | Rabigh | King Abdullah Economic City | Riyadh | Jeddah | Khulais |Nišava District :
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