Job Description

Clinical Trial Administrator



Category: Clinical Development



Location: Kuala Lumpur, Kuala Lumpur, MY






Do you want to be part of a dynamic team, working in an international environment that drives clinical trial activities? Are you a detail-orientated person who is passionate about clinical trials and likes planning and coordinating? Then keep reading - we may have just the right job for you as a Clinical Trial Administrator. 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. The position of Clinical Trial Administrator is based in Kuala Lumpur, Malaysia, reporting to the Clinical Operations Manager.

The position
As a Clinical Trial Administrator, you will be liable for assisting activities of the Malaysia Affiliate trial teams (Line Managers and Clinical Research Associates) for assigned clinical trials in accordance with Novo Nordisk\xe2\x80\x99s policies and procedures, SOPs (Standard Operating Procedures), local legislation, and GCP (Good Clinical Practice) requirements.
With your structured approach and high-quality mindset, one of your main duties will be to establish and maintain the Trial Master File (TMF) in accordance with standard operational procedures (SOP), including uploading and updating of information, indexing and Quality Control of trial documents in our different IT Clinical systems as well as IT project tools.
Your duties will also include the following:

• Management of all trial documentation for assigned clinical trials, covering all involved within the affiliate including documentation to assist affiliates in Health Authorities and Ethic Committees submissions, ensuring overview of local requirements. Assist audit and inspection at the affiliate or site as applicable.
• Timely updating of relevant trial logs in the system and complete check of trial documentation in the system. With the Start-Up Specialist, work on the preparation of clinical trial application dossier. Preparation of SIV (site initiation visit) kits & dispatch to sites as per initiation plans.
• Providing Investigator Trial Master Files (ITMFs) core input and additional patient material during a course of study. Coordination with CRAs to ensure tracking tools are up to date for timely and accurate safety reporting.
• Assisting with clinical trial supplies logistics including logging and shipping. Maintaining a record of acknowledgement of receipt for each shipment set to customers (hospitals, vendors, etc.). Procurement of materials from vendor, ensure vendor collaboration & follow up till delivery to site office.
• Other relevant administrative tasks (can include drafting & producing letters, reports, taking quotes from vendors and generating PO, management of mailing lists, generic mailboxes, and assistance in the organization of local meetings and department meetings including preparation & distribution of minutes).

Qualifications

• A bachelor\xe2\x80\x99s degree in a science-related discipline and are looking to start your clinical trials career.
• Knowledge of GCP and experience with regulatory documents, a core understanding of medical terminology and clinical trial activities in relation to the execution of a clinical development plan - a significant advantage
• Minimum 1 year of experience in multi-country/regional/global set-up from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO)
• Fluent English verbal and writing skills, and Bahasa Malaysia with cross-cultural awareness and ability to collaborate in a multi-national environment IT proficiency (including MS Office: Outlook, Excel, Word, PowerPoint). Knowledge of eTMF systems such as Veeva Vault and COSMOS is considered an advantage.

Working at Novo Nordisk
At Novo Nordisk, we don\xe2\x80\x99t wait for change. We drive it. We\xe2\x80\x99re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We hold the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales \xe2\x80\x93 we\xe2\x80\x99re all working to move the needle on patient care.


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


Deadline
15 December 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\xe2\x80\x99re life changing.


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