Clinical Research Associate - Mumbai

Novo Nordisk View all jobs

  • Bangalore, Karnataka
  • Permanent
  • Full-time
  • 3 days ago
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Accept CloseSearch by KeywordSearch by LocationLoading...CategorySelect how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Clinical Research Associate - MumbaiCategory: Clinical DevelopmentLocation:Bangalore, Karnataka, INJob title: Clinical Research Associate (CRA)Location: MumbaiDepartment: CDC IndiaTravel: Flexible travel requiredAbout Novo NordiskNovo 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 summaryThe 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 you will work with
- External: Investigators, study nurses/co-ordinators, 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.
  • Education and experience
- 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
  • 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.Working at Novo NordiskAt 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.ContactTo submit your application, please upload your CV online (click on Apply and follow the instructions).DeadlineApril 27th, 2026DisclaimerIt has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organisations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment, or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've 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 what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're 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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