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CRA Manager

1 month ago

Mumbai, India Novo Nordisk AS Full time

Department – Clinical Medical Regulatory (CMR)

Do you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people? If you find challenges inspiring and want to drive innovation within a multifaceted and inspiring working environment, you may be our new CRA Manager for the Clinical Medical Regulatory team based at Mumbai. If you have what it takes to be a part of Novo Nordisk team, Apply now

The position

This role requires someone to Coordinate, in partnership with the COM (Clinical Operation Manager) and CDC-TM (Trial Managers), the clinical trial set-up at a local level to ensure appropriate site and resources allocation. Manage local clinical projects, ensuring they are executed in a timely and effective manner, within budget and complying with regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice) and NN SOPs (Standard Operating Procedures). Provide clinical trial related communication and insight to internal and external stakeholders. Manage and coach CRAs (Clinical Research Associate). As a CRA Manager you will be responsible to:

Recruit and Develop CRAs and implement necessary actions to improve their performance. Lead quality clinical trial projects (CDP and/or local) in the country. Provide trial related communication and insight to key internal and external stakeholders. Coordinate the clinical trial set-up in partnership with the COM. Maintain ongoing communication with Ethics Committees and the Health Authority, ensuring the Central and local (as applicable) Ethic Committee is provided with the documents requested.

Qualifications

To be successful in this role, you should have the following qualifications:

8 to 10 years of experience in managing global clinical trials as CRA/Sr. CRA (approx. 6 yrs) and Team lead/Trial Manager (aprox. 2 yrs). Currently leading/managing project team of CRAs and or CTAs. Candidates with prior experience in handling Diabetes/Obesity/OSCD (Other Serious Chronic Diseases)/Haemophilia/Growth Hormone disorders trials will be preferred. Experience in managing clinical trials from study start-up to study close outs. Must be willing to travel approx. 10 days/month. Graduate or Postgraduate in Pharmacy or Lifesciences or other related fields.

About the department

The Clinical Research department at Novo Nordisk India is based in Mumbai. We have a team of dedicated professionals working on cutting-edge clinical trials in the field of diabetes and other serious chronic diseases. Our department is fast-paced and dynamic, with a focus on delivering high-quality clinical research projects. Join us and be part of a team that is making a difference in the lives of patients around the world.

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