Feasibility Specialist

2 weeks ago

Kuala Lumpur, Malaysia Novo Nordisk Full time

**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 position tasks are, but not limited to:

- Conducting data-driven country and site feasibility 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 (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 collaboration 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 engage in study strategies.
- Collating lessons learned from all trials and using them while assessing the feasibility of future trials.

**Qualifications**

We expect you to have:

- Bachelor or another degree in sciences or equivalent as a minimum, e.g., nursing, medical, pharmacy etc.
- ICH-GCP trained and if applicable certified.
- Minimum 2 years of experience as a 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**

**Deadline**
28 July 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.

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