Clinical Research Job at Novo Nordisk, Mumbai
Are you ready to manage clinical trial sites and ensure high-quality research execution? This Clinical Research Associate (CRA) role offers a great opportunity to work in global clinical development. You will oversee clinical trial sites, ensuring compliance, patient safety, and data integrity. The position involves risk-based monitoring and collaboration with cross-functional teams. This Clinical Research Job at Novo Nordisk Careers in Mumbai is ideal for professionals with CRA experience looking to grow in multinational trials. Join a global healthcare leader and contribute to innovative medicine development.
About Novo Nordisk:
Novo Nordisk is a global healthcare company with over 100 years of experience in driving innovation. The company focuses on chronic diseases such as diabetes, obesity, and other serious conditions. With a strong commitment to research and development, Novo Nordisk aims to improve patient lives worldwide through advanced therapies and sustainable healthcare solutions.
Job Details:
- Job Title: Clinical Research Associate (CRA)
- Location: Mumbai
- Base Location Mentioned: Bangalore
- Department: CDC India / Clinical Development
- Job Type: Full-Time
- Experience Required: 2–4 Years
- Travel Requirement: Flexible travel required
- Application Deadline: April 27, 2026
Job 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 risk‑based monitoring and proactive risk management, working closely with site staff and cross‑functional teams to ensure successful trial execution.
Key Responsibilities:
Site management & monitoring
- Serve as primary Novo Nordisk liaison to assigned clinical sites and cross‑functional study teams.
- Conduct on‑site and remote monitoring visits per the Monitoring Plan, Protocol, ICH‑GCP, 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.
Quality oversight
- 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 ICH‑GCP, regulations and internal SOPs.
Stakeholder collaboration & communication
- Build strong relationships with site staff, investigators and key stakeholders (Trial Managers, Study Start‑up, Vendor Managers, Data Management, etc.).
- Participate in investigator/co‑ordinator 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.
Who will you work with?
- 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
Educational Requirements for this Job:
- Degree in Medicine or related field
- 2–4 years of CRA experience
- Experience in multinational clinical trials (Phase 2–3 preferred)
- Knowledge of ICH-GCP and regulatory guidelines
Skills, knowledge, and competencies:
- Strong knowledge of ICH‑GCP, regulatory requirements and clinical trial methodology.
- Proven track record delivering high‑quality clinical trial execution in compliance with ICH‑GCP, regulations and SOPs.
- Excellent stakeholder management and communication skills (written, verbal and non‑verbal).
- 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 problem‑solving and proactive risk‑mitigation skills.
- Willingness to embrace new ways of working, continuous improvement and digital tools.
- Flexibility to travel as required.
Benefits of the Clinical Research Job:
- Opportunity to work with a global healthcare leader
- Exposure to international clinical trials
- Strong career growth in clinical development
- Collaborative and inclusive work culture
- Professional and personal development opportunities
- Contribution to innovative treatments for chronic diseases
- Dynamic work environment with travel exposure
