Clinical Trial Start-up Manager
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Søborg
- Clinical Development and Medical
- Søborg
Do you want to be part of getting new and better treatments out to millions of people? Do you have extensive experience in setting-up clinical trials and are you able to take full responsibility for the entire start-up phase of a clinical trial? Then you could be our new Trial Start-up Manager.
About the department
The clinical trial operation activities are anchored in our R&D organisation under Global Development. We offer a challenging position where you will be a key player setting up global clinical trials, thereby ensuring the high-quality data and scientific documentation required by health authorities.
We have recently initiated the journey into New Trial Management with an agile and simplified way of driving clinical trials, new roles and a culture that values small and flexible teams.
As a Trial Start-up Manager in GLP-1, CV & Outcomes you will be working on trials ranging from small specialised trials in areas new to Novo Nordisk to large cardiovascular outcome trials with thousands of subjects.
The position
In the position as a Trial Start-up Manager, you are accountable for project managing all trial start-up activities from protocol outline to the initiation of patient recruitment in phase 2-4. In collaboration with Trial Manager(s), you will ensure that project key deliverables are met on time at a high quality by using your extensive operational trial management expertise.
Drawing on your experience, you will be accountable for:
- Leading the protocol outline and protocol development
- Leading the development of Patient Information/Informed Consent
- Developing all documents, training materials and manuals for both clinical sites and for patients
- Coordinating the development of documents for the Clinical Trial Application package, and managing questions received from Ethic committees
- Managing stakeholders at all levels including clear communication on deliverables
- Providing input to the setup of our clinical trial systems
As Trial Start-up Manager you will be working closely with both internal and external stakeholders such as the Trial Project Manager, members from local affiliates and suppliers. You are expected to communicate with external vendors and be able to handle a variety of situations, e.g. take part in critical contract negotiations in case of escalations.
Applying your talent for project management, you keep your trial(s) moving forward, with an eye on challenges and risks to meet the deadlines and of course considering compliance in every aspect. Some travelling is expected.
Qualifications
You hold a MSc or BSc in Natural Science and have relevant experience with trial management and most importantly have solid experience in managing start-up activities for global clinical trials. You must have comprehensive GCP knowledge and you are expected to have some knowledge of clinical IT systems (e.g. EDC, IWRS).
As a person, you are curious and is used to navigate within unknown areas. You are a high performer with a documented track record of experience. You are in possession of excellent communication, presentation and negotiation skills. You are a team player and are fluent in written and verbal English. You create consensus across professional and geographical borders and build trust among colleagues to establish mutually profitable working relationships.
Working at Novo Nordisk
At Novo Nordisk, we are the world leader in diabetes care and a major player in obesity treatment, haemostasis management, growth hormone therapy and hormone replacement therapy. Our R&D and production facilities span five continents and our people are united by their passion for creating sustainable solutions.
Contact
For further information, please contact Randi Rahbæk at +45 3079 8419
Deadline
12 January 2020. Please submit your cover letter, CV and other relevant documentation online.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 30.12.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Afdelingsleder
- Søborg
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