Job Description

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Feasibility Specialist

Category: Clinical Development and Medical

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? Would you like to be involved in the planning of the trial portfolio on a strategic level? Then keep reading - we may have just the right job for you! Novo Nordisk Malaysia has opened a role for a Feasibility Specialist, join us and apply today!

About the Department

The Clinical Medical Regulatory and Quality (CMRQ) 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, Regulatory, and Quality Assurance. The position of Feasibility Specialist is to be in Kuala Lumpur, the capital of Malaysia, and report to the Clinical Operations Manager.

The Position
The successful candidate will conduct a data-driven review and site feasibility for studies including inputs to protocol design (if relevant), following the currently proposed Global Trial Planning (GTP), with International Conference on Harmonization-Good Clinical Practice (ICH-GCP), and with the applicable regulatory requirement(s).

The position tasks are, but not limited to:

• Conducting data-driven country and site feasibility for studies, including inputs to protocol design (if relevant). Identifying potential site lists based on historical experience and inputs from the clinical operations team. Ensuring site-specific confidentiality disclosure agreements Clinical Document Architecture (CDA) are executed prior to sharing the feasibility questionnaire.
• Collaborating with the local clinical operations teams, and regulatory, medical, market, and pricing teams for conducting feasibility, site selection, and start-up activities. Providing country feasibility inputs into Trial Portfolio Review.
• Constantly maintaining and generating relations with Investigative Sites. Maintaining and refining the internal site database in cooperation with Study Start-up, Clinical Operations, and Process Improvement.
• Building and maintaining a sound knowledge of historical performance, patient treatment pathways, competitor trials, Patient networks, advisory groups, and country clinical research environment for new and established therapy areas. Delivering final confirmation on country allocation to the Global Trial Planning (GTP) Team. Building and maintaining relationships with internal and external stakeholders to develop clear communication methods to support study strategies.
• Collating lessons learned from all trials and use them while assessing the feasibility of future trials.

Qualifications

Our ideal candidate is a strong team player, can work independently, and is well-structured with a sense of detail and a good overview at the same time. It is important that you have a proactive attitude, can manage deadlines, and that you are able to work with multiple and frequently changing priorities. You have very good communication skills and build relationships with various stakeholders.

We expect you to have:

• Completed Bachelor\'s degree or higher qualifications in Pharmacy, Medicine, Nursing, Life Sciences or another related field.
• ICH-GCP trained and if applicable certified.
• Minimum 2 years of experience as a Clinical Research Associate (CRA) is required.
• Experience in multinational clinical trials phase 1-4 from site feasibility till site closure.

Working at Novo Nordisk

At Novo Nordisk, we don\'t wait for change. We drive it. We\'re 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 embrace 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 to manufacturing, marketing and sales - we\'re all working to move the needle on patient care.

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

Deadline
28 Feb 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