Clinical Operations Manager**Category**:Clinical Development**Location**:Kuala Lumpur, Kuala Lumpur, MY-**About the department**- The Clinical, Medical and Regulatory (CMR) department is one of the key functions that enable 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 is to be located in Kuala Lumpur the capital of Malaysia, and reports to the CMR Director.**The position**- In this role, you will oversee and manage the Clinical Trial Unit ensuring high-quality, timely, and cost-effective conduct of all clinical trials in accordance with local regulations, Helsinki Declaration, GCP, (Good Clinical Practice) and Novo Nordisk SOPs (Standard Operational Procedures).- Other role accountabilities are as follows, but are not limited to:- Forecast and properly execute the local clinical research unit budget.- Manage the conduct of all Novo Nordisk-sponsored clinical trial projects in collaboration with the CTLs (Clinical Trial Liaison).- Manage a team comprising of Project managers, Clinical Research Associates (CRAs) and Clinical Trial Administrators (CTAs).- Accountable for ensuring all the KPIs of your unit are met including timely recruitments, quality reporting, audit readiness etc.- Develop and maintain relationships with the KOLs (Key Opinion Leaders), Ethics Committees, Health Authorities, CRC (Clinical Research Coordinator), and CRM (Customer Relationship Management).**Qualifications**- Have at least 7+ years of experience in the clinical operations area and 4-5 years of experience in people management.- Solid knowledge of clinical trial processes and protocols.- Knowledgeable in ICH-GCP, local requirements, and Novo Nordisk 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.- Degree or higher qualification in Pharmacy, Life Sciences, or another related field. Have high proficiency in verbal and written communication skills with the ability to manage complex projects with strong planning, problem-solving, and organizational skills.**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 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 to manufacturing, marketing and sales - we're all working to move the needle on patient care.**Contact**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're life changing.- #LI-AMS1
