Clinical Operations Lead

2 weeks ago

Søborg, Denmark Novo Nordisk Full time

The position

We are looking for a Clinical Operation Leads in all our 5 areas. In this position, you take on a senior role with extensive responsibilities, being accountable for all aspects of the operational start-up and initiation activities of a clinical trial. Your main responsibilities will include: Defining, setting up and preparing our clinical trials with operational excellence to the benefit of participants and the company Being a strong contributor towards translating our strategies and aspirations into operational actions and excellence Assuming accountability for the start-up and initiation of 1-2 clinical trials depending on complexity Being accountable for trial start-up activities from protocol outline to successful patient recruitment with great exposure to the organisation and cross-functional stakeholders (e.g., Strategic Project Teams, Trial Squads, Medical and Science Teams, Regulatory Affairs etc.) Qualifications You will be a great asset to our team because you have: • A MSc in Natural Science and at least 3 years of relevant experience from the equivalent role, or a BSc in Natural Science with at least 5 years of experience from a relevant role within Clinical Operations (e.g. Global Trial Manager, Clinical Research Associate, study nurse or Clinical Trial Administrator)• Strong clinical project management experience and the ability to impact the execution and improvement of core clinical processes• Knowledge and experience in clinical trial methodology and operational aspects of trial initiation including solid knowledge and experience in clinical IT systems (e.g. EDC, IWRS/RTSM etc) • Excellent planning, communication, coordination, and collaboration skills • Professional proficiency in English If you are curious to know more about Clinical Operations in Novo Nordisk, the different positions, job content and qualifications, then please have a look here . About the department In Novo Nordisk, we are working within 5 areas: Obesity, Liver Diseases & Devices: We drive the obesity, liver diseases & device portfolio by developing new and better treatments for people with obesity and/or liver diseases and also cover the device development. We are responsible for the establishment of medical and clinical strategies as well as for the execution of clinical trials within our area. We cover all phases (1-4) of the clinical trials including decentralized trials and paediatric studies. Diabetes: We cover clinical activities from early phase 1 trials on new innovative treatments to large global phase 3a programs and phase 3b/4 life cycle management activities on our marketed products including non-interventional/pragmatic studies to generate real-world evidence data. CagriSema: To accelerate and expand the promising novel therapy CagriSema within obesity and diabetes, a dedicated area has been established as part of Clinical Drug Development. Here, you will help us deliver innovative medicines and drive improved patient outcomes as you take on responsibility for the planning and execution of global clinical trials in Phases 1-4. By contributing to our shared mindset of collaboration and curiosity, you bring innovation to our clinical trials and pave the way for the success of our mission. OSCD & Outcomes: We drive the entire spectrum of clinical activities on new innovative treatments within the Cardiovascular diseases, Heart failure, chronic kidney diseases and Alzheimer disease portfolio from phase 1 trials to large phase 3a programs and phase 3b/4 life cycle management activities. Rare Disease and Advanced Therapies: Novo Nordisk has for many years been pioneers in rare bleeding disorders (such as haemophilia), and rare endocrine disorders (such as growth hormone deficiency) and we keep expanding into more indications and new therapeutic areas. We currently have several ongoing Phase 1-4 trials within Rare Blood, Rare Bleeding and Rare Endocrine Disorders. We are also responsible for the clinical execution of the Novo Nordisk stem cell portfolio. Today we span over various technologies such as proteins, monoclonal antibodies, cells, and gene therapy. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a world-leading agile company in a dynamic industry, and we know that what got us to where we are today is not necessary 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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

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