Novo Nordisk Trial Manager Job For BPharma – Apply Online
CDC- Trial Manager
Category: Clinical Development
Location: Mumbai, Maharashtra, 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 Project Manager (CDC Trial Manager) for the Clinical Medical Regulatory team based in Mumbai. If you have what it takes to be a part of the Novo Nordisk team, apply now!
The position
As a CDC Trial Manager, you are the main accountable person in making sure that deliverables are met as per project timelines, within budget, and comply with Protocol, country regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice), and NN SOPs (Standard Operating Procedures). Key responsibilities include:
- Driving assigned clinical trial from feasibility to clinical trial reporting.
- Planning activities, site selection, Ethics committee and health authority submissions, starting-up trial sites, and organizing investigator meetings.
- Training site staff, CRAs, CTAs, and start-up teams about the protocol and other protocol-related information, providing operational and therapeutic expertise to the CDC project team, and achieving deliverables within agreed timelines and in accordance with scientific, quality, and regulatory requirements.
- Ensuring effective communication of all trial/project-related issues between HQ, CDC, the region, and other internal/external stakeholders.
- Representing CDC countries in relevant study meetings and organizing meetings such as Trial Squad Meetings, Monitor meetings, Investigator meetings, and Study Result meetings.
Qualifications
To be successful in this role, you should have the following qualifications:
- A bachelor’s degree in life science, pharmacy, nursing qualification, or equivalent.
- At least 5+ years of experience in clinical monitoring.
- Basic GCP qualification and a high level of understanding of GCP requirements.
- Advanced-level knowledge of Excel and PowerPoint presentation.
- Good working knowledge of electronic clinical trials systems such as IMPACT, EDC, IWRS, and electronic TMF (Trial Master File).
- Good communication skills and the ability to collaborate with internal and external stakeholders.
About the department
Novo Nordisk is a Denmark-based multinational with leadership in diabetes. Novo Nordisk India affiliate office is in Bangalore and has more than 1,400 people working across the country in various functions. The position Project Manager (CDC Trial Manager) 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 select appropriate sites to allocate local clinical trials, liaising with the COM and Head.
Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing.
Contact: To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).
Deadline: 03rd May, 2024
Keywords: Novo Nordisk, CDC Trial Manager, Clinical Development, Mumbai, Maharashtra, Clinical Trials, Healthcare. Novo Nordisk Trial Manager Job For BPharma – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
