Job Description

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Clinical Trial Manager

Category: Clinical Development

Location:

Kuala Lumpur, Kuala Lumpur, MY

Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding Clinical Operations and bringing attention to key project management challenges? Then you could be our new Clinical Development Centre (CDC) Trial Manager. Apply now for a life-changing career!

About the department

The Clinical, Medical, and Regulatory (CMR) department is one of the key functions that enable the business strategy through the effective execution of functional goals, in the areas of Clinical Research, Medical Affairs and Regulatory. This full-time permanent position is based in Kuala Lumpur and reports directly to the Clinical Operations Manager.

The position

As a CDC Trial Manager, you will be the main liable person for 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 Novo Nordisk SOPs (Standard Operating Procedures).

Key responsibilities include:

• Driving assigned clinical trials from the feasibility to Clinical trial reporting. Manage activities including planning, site selection, Ethics committee and health authority submissions, starting-up trial sites and organizing investigator meetings.
• Training site staff, CRAs (Clinical Research Associates), CTAs (Clinical Trial Administrators), start-up teams about the protocol and other protocol related information, providing operational and therapeutic expertise to the CDC project team, achieve deliverables (including recruitments) within agreed timelines and in accordance with scientific, quality, and regulatory requirements.
• Ensure effective communication of all trial/project related issues between Headquarters, CDC, the region, and other Internal/external stakeholders. Responsible for representing CDC countries in relevant study meetings and organizing these meetings: Trial Squad Meetings Monitor meetings, Investigator meetings and Study Result meetings.
• Review and customisations of all trial related documents as relevant, coordinate contract finalization process as decided by the country legal responsible.
• Ensure all the sites are activated as early as possible. Escalate any projected delay to the clinical operations manager and/or CDC Head. Ensuring all the sites are audit and inspection ready.

Qualifications

• You should have a bachelor\'s degree in Life Science, Pharmacy, Nursing qualification or equivalent.
• You should have at least 5+ years of experience in clinical monitoring with 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 trial systems - VEEVA, EDC, IWRS, electronic TMF.
• Good Communication and should be able to collaborate with internal and external stakeholders.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We\'re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we\'re all here - to ensure that people can lead a life free of chronic disease.

Contact
Please send your CV online (click on Apply and follow the instructions).

Deadline
18 Dec 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.

Novo Nordisk