Clinical Research Associate

2 weeks ago

Mumbai, India Novo Nordisk Full time

**Department: Clinical Development Centre**

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 Clinical Research Associate for the Clinical Development team based at Bangalore.

**The Position**
- The Clinical Research Associate (CRA) is the primary point of contact between site staff and Novo Nordisk. In this role the CRA acts as ambassador for the company.
- The CRA is responsible for taking leadership of site management for the selection (if applicable) and initiation of sites as well as conduction and closing activities of the appointed studies in compliance with local regulations,
- The CRA coordinates with CRM and RTM and communicates to them progress and critical issues that may impair trial progress. In some cases, the CRA may have direct contact with the ITM.
- Efficient and accurate site selection visits (as appropriate including analysis of site logistics, site performance/quality indicators)
- Accountability for patient recruitment strategies, including implementation of mitigation actions
- Has good knowledge of trial product and trial protocol and train site staff in trial procedures, handling of trial product and documents
- Visit trial sites regularly in accordance with the protocol to perform monitoring activities required
- Proactive use of IT Systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team\
- Guide site staff in preventing deviations that will compromise integrity and quality of trial-conduct

**Qualification**
- Graduate in Medicine, Science, Pharmacy or other relevant
- ICH GCP trained and if applicable certified
- Additional qualification on clinical research would be preferred
- 2 - 4 years of experience as a CRA
- Experience in 1-2 multinational clinical trials phase 2-3 from site initiation till site closure

**About the department**

Novo Nordisk India affiliate office is in Bangalore & has more than 1,400 people working across the country in various functions. The Clinical Research Associate position is based in Bengaluru and reports to the Clinical Operations Manager.

**Working at Novo Nordisk**

Novo Nordisk is a Denmark based multinational with leadership in diabetes. Novo Nordisk India affiliate office is in Bangalore & has more than 1,400 people working across the country in various functions. The position Clinical Team Lead (CTL) reports directly to the Clinical Operations Manager (COM) and demands responsibility to recruit and develop the CRAs to achieve the project deliverables and implement necessary actions to support and improve their performance. Co-monitoring visits with the CRA and, in partnership with the COM, monitor the quality of the clinical trial execution, quality audits and inspection issues. 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. Identify new sites, coordinate site assessments (if required) and elect appropriate sites to allocate local clinical trials liaising with the COM and Head.

**Contact**

**Deadline**

2nd September, 2023.

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.

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