Job title: Clinical Research Associate (CRA)
Location: Delhi
Department: CDC India
Travel: Flexible travel required
About Novo Nordisk
Novo Nordisk is a global healthcare company with a strong heritage in research and development and a clear commitment to improving patients lives. We are looking for talented people who share our values and want to make a difference. As a CRA in our Site Monitoring Excellence team you will contribute directly to the execution of high-quality clinical trials that support development of innovative medicines.
Role summary
The CRA provides strategic oversight and management of clinical trial sites to ensure protocol compliance data integrity and protection of patient safety and rights. You will drive study quality and performance through riskbased monitoring and proactive risk management working closely with site staff and crossfunctional teams to ensure successful trial execution.
Key responsibilities
- Serve as primary Novo Nordisk liaison to assigned clinical sites and crossfunctional study teams.
- Conduct onsite and remote monitoring visits per the Monitoring Plan Protocol ICHGCP internal SOPs and applicable regulations.
- Monitor patient safety and data integrity manage queries and adverse event reporting and resolve discrepancies in line with study requirements.
- Track site performance recruitment retention and data delivery to meet timelines and quality objectives.
- Manage IMP study supplies essential documents and site equipment accountability.
- Provide site training and continuous operational support on protocol systems and compliance requirements.
- Maintain accurate trial documentation including the Investigator Trial Master File per the TMF plan.
- Act as an ambassador for Novo Nordisk values at site level.
- Implement RBQM principles to identify assess and mitigate risks throughout study conduct.
- Support timely data cleaning in line with the Data Flow Plan.
- Maintain inspection readiness and provide support during audits and inspections.
- Ensure clinical activities are conducted to high quality standards in accordance with ICHGCP regulations and internal SOPs.
- Build strong relationships with site staff investigators and key stakeholders (Trial Managers Study Startup Vendor Managers Data Management etc.).
- Participate in investigator/coordinator meetings CRA training and project meetings and share insights to support continuous improvement.
- Provide site feedback to inform protocol amendments patient engagement initiatives and operational planning.
- External: Investigators study nurses/coordinators KOLs IRBs/Ethics Committees local health authorities patient advocacy organizations vendors/suppliers.
- Internal: Trial squads and Global Project Teams CDC/Affiliate clinical teams CMMs Data Management Clinical Operations Management Country Management Teams.
- Graduate in Medicine Science Pharmacy or other relevant
- Minimum 2 -4 years of experience working as a CRA.
- Experience in 1-2 multinational clinical trials phase 2-3 from site initiation till site closure
- Strong knowledge of ICHGCP regulatory requirements and clinical trial methodology.
- Proven track record delivering highquality clinical trial execution in compliance with ICHGCP regulations and SOPs.
- Excellent stakeholder management and communication skills (written verbal and nonverbal).
- Able to work independently and collaboratively in dynamic environments.
- Strong organisational and time management skills; able to prioritise across multiple sites/studies.
- Project management capabilities attention to detail integrity and commitment to patient safety.
- Proficiency with EDC CTMS eTMF and other clinical systems.
- Strong problemsolving and proactive riskmitigation skills.
- Willingness to embrace new ways of working continuous improvement and digital tools.
- Flexibility to travel as required.
Working at Novo Nordisk
At Novo Nordisk we use our skills dedication and ambition to help people with diabetes and obesity and other chronic diseases. We offer the chance to be part of a truly global workplace where passion and engagement are met with opportunities for professional and personal development.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.
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