Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post: CRA/Trainee Clinical Research Associate
Job Description
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.
- You will be responsible to coordinate with regulatory team for HA dossier preparation and submission.
- You will coordinate with local trial manager for EC dossier preparation and submission.
- You will also ensure collection and review of green light documents as per NN Sop’s. You will be involved in planning and conducting site monitoring visits as per the protocol timelines.
- You will review and ensure maintenance of investigator trial files on regular basis.
- You will prepare monitoring reports and upload into IMPACT after review by PM/LTM within specified timelines. You will also ensure smooth closeout of the study as per guidelines.
Last but not least, acting in line with ethical standards of the organization by personally observing when in the field that we all live with BE policies.
Candidate Profile
- You hold 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.
- You have excellent communication & influencing skills and can drive projects and processes.
- You are fluent in both written and spoken English.
Additional Information:
Experience: 1-2 Years
Qualification: Graduate/Post graduate in science, Pharmacy or Medical
Industry Type: Pharma/ Biotech/Clinical Research
Location: Bangalore- Karnataka
Requisition ID: 37247BR
Job Category: Clinical Trial Management
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