Clinical Operations Manager Operational Excellence

Clinical Operations Manager Operational Excellence

**Category**:Clinical Development

**Location**:Kuala Lumpur, Kuala Lumpur, MY

**About the department**
The Clinical, Medical and Regulatory (CMR) Department is dedicated to driving the success of our clinical trials and ensuring regulatory compliance. The Clinical, Medical and Regulatory Department is one of the key functions that enables the business strategy through effective execution of functional goals, in the areas of Clinical Research, Medical Affairs and Regulatory.
The position of Clinical Operations Manager will be located in Kuala Lumpur, the capital of Malaysia, and reports to Clinical Development Center Head.

**The position**
In this role, as a member of the Clinical Development Centre (CDC) management team, you will be responsible for establishing the appropriate strategies and teams for the CDC countries to ensure operational excellence in key areas, following the guidelines of the International Conference on Harmonization-Good Clinical Practice (ICH-GCP), Novo Nordisk (NN), and country-specific requirements. This is to guarantee that the NN Quality Management System (QMS) is fully operational in all CDC countries, encompassing Clinical Quality & Compliance, Clinical Training, and Innovation & process improvements.
The Clinical Operations Manager will be in charge for 3 integrated functions: Feasibility, Start-up, Quality and Training of the clinical team members of the CDC.
- Feasibility: plan the robust and data driven feasibility function so that site selection can be data driven.
- Study Start-Up (SSU): plan the robust SSU strategy from the CDC so that overall allocated study can be started within very competitive timeline.
- Quality and Training; Drive the pro-active quality and training strategy to assure audit and inspection readiness and boost the GCP and compliance mindset.

**Qualifications**
- Bachelor’s degree or higher qualification in Pharmacy, Life Sciences, or another related field.
- Minimum of 7+ years of experience in the clinical operations area and 4-5 years of experience in people management.
- Experience in GCP audits and inspections is highly preferred with a solid knowledge of clinical trial processes and protocols. Awareness on LEAN principal and methodology of other operational excellence framework will have added advantage.
- Knowledgeable in ICH-GCP, local requirements, and Novo Nordisk’s Standard Operating Procedures (SOPs). You must also be able to adapt to changes and manage the unit and clinical trials in control of the innovative use of new IT systems.
- Strong functional and cross functional stakeholders’ management and situation leadership. You have highly proficient verbal and written communication skills with the ability to manage complex projects with strong planning, problem-solving, and organizational skills.

**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 recognise 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**

**Deadline**
10 February 2025
- 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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