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.
Post : Clinical Research Associate
Job Description
About the department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life.
The position
• As a CRA you will be responsible for the smooth conduct of all clinical trials sponsored by Novo Nordisk India in accordance with good clinical research practice (GCP) guidelines by NN and in line local regulatory requirements.
• In this role you will act as an ambassador for the company, and you are a primary point of contact between site staff and Novo Nordisk.
• You will lead the site management activities for the selection (if applicable) and initiation of sites as well as conducting and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, Novo Nordisk procedures and protocol requirements to ensure data quality and study subject protection. You are also responsible for recruitment at site levels.
• You will be responsible for efficient and accurate site selection visits, performing monitoring activities.
• Guide and train staff on safety information handling and systems to prevent deviations that may lead in comprising integrity and quality of trail conduct.
Candidate Profile
• You hold a graduate degree in Medicine, Science, Pharmacy or other relevant from a reputed institution. You have minimum experience of 1-4 years in Clinical Research.
• As a Clinical research professional, you should have solid experience in 1-2 multinational clinical trials phase 2-3 from site initiation till site closure.
• You are required to be trained in ICH GCP guidelines and if applicable certification is also preferred.
• Strong strategic and analytical capabilities, with demonstrated experience in analysing complex situations
• A strong track record in thorough planning, execution and follow-up is required, with a creative and innovative attitude that will enable you to drive initiatives with operational excellence in mind
Additional Information
Qualification : Graduate degree in Medicine, Science, Pharmacy
Location : Bangalore, India
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical Development and Medical
End Date : 6th May 2022
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