CDC- Trial Manager

☞ Novo Nordisk

Vue: 103

Jour de mise à jour: 18-05-2024

Localisation: Mumbai Maharashtra

Catégorie: Science La main doeuvre

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le contenu du travail

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 at Mumbai. If you have what it takes to be a part of Novo Nordisk team, Apply now!

The position
As a CDC Trial Manager is the main accountable person in making sure that deliverables are met as per project timelines, within budget and complying 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 the feasibility to Clinical trial reporting.
  • The activities include planning, site selection, Ethics committee and health authority submissions, starting-up trial sites, organize investigator meetings.
  • Training Site staff, CRAs, CTAs, start-up teams about the protocol and other protocol related information, providing operational and therapeutic expertise to the CDC project team, achieve deliverables within agreed timelines and in accordance with scientific, quality, and regulatory requirements.
  • To ensure effective communication of all trial/project related issues between HQ, CDC, the region, and other Internal/external stakeholders.
  • Responsible for representing CDC countries in relevant study meetings and organize these meetings: Trial Squad Meetings Monitor meetings, Investigator meetings, Study Result meetings.

Qualifications
To be successful in this role, you should have the following qualifications:
  • You should have a bachelor’s degree in life science, pharmacy, or nursing qualification or equivalent.
  • You should have least 5+ years of experience in clinical monitoring.
  • Basic GCP qualification and high level of understanding of GCP requirements.
  • You must have advanced level knowledge of Excel and PowerPoint presentation.
  • Good working knowledge of electronic clinical trials systems – IMPACT, EDC, IWRS, electronic TMF (Trial Master File).
  • Good Communication and should be able 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 & 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 elect 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

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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Date limite: 02-07-2024

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