Novo Nordisk is located in India in an office of around 1000 plus engaged people all supporting our affiliates with issues related to HR, Marketing, Finance, Medical, Clinical, Regulatory, Quality, IT and Legal. Their main objective is to ensure they have the best organization and right people in place to ensure continued growth in the business area. Their role is to support the affiliates in rolling out and executing programs to the wider Novo Nordisk organization.
Novo Nordisk is looking for an CRA/Trainee Clinical Research Associate, who would ensure smooth conduct of all clinical trials sponsored by NNIPL in accordance with good clinical research practice guidelines by NN A/S and local regulatory requirements.
Job Title: CRA/Trainee Clinical Research Associate
Qualifications:
- Graduate/Post graduate in science, Pharmacy or Medical.
- Additional qualification in clinical research would be preferred.
- Minimum 1 year experience trainee CRA or 1-2 years of experience in clinical research in a CRO or a Pharma company.
- Excellent communication & influencing skills and can drive projects and processes.
- Fluent in both written and spoken English.
Job Description:
- Responsible to coordinate with regulatory team for HA dossier preparation and submission. Coordinate with local trial manager for EC dossier preparation and submission.
- Ensure collection and review of green light documents as per NN Sop’s.
- Planning and conducting site monitoring visits as per the protocol timelines.
- Review and ensure maintenance of investigator trial files on regular basis.
- Prepare monitoring reports and upload into IMPACT after review by PM/LTM within specified timelines.
- Ensure smooth closeout of the study as per guidelines.
