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CRA Manager
Category: Clinical Development
Location:
Bangalore, Karnataka, IN
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 Bangalore. 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)/Hemophilia/Growth Hormone disorders trials will be preferred
- Experience in managing clinical trials from study start-up to study closeouts’
- Must be willing to travel approx. 10 days/month
- Graduate or Post Graduate in Pharmacy or Lifesciences or other related fields
About the department
The Novo Nordisk India affiliate office is located in Bangalore and has more than 1400 people working across the country in various functions. Our Marketing Department is a dynamic, creative, and collaborative team committed to data-driven strategies, customer-centric design, innovative digital practices, and delivering measurable results. As part of our department, you’ll have the opportunity to contribute to diverse projects, continually grow your skills, and directly impact our company’s growth trajectory.
Working at Novo Nordisk
At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.
Contact
To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).
Deadline
09th April, 2024
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.