Clinical Trial Administrator
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Ørestad
Do you want to be part of a dynamic team managing clinical trial start-up activities? Do you thrive in working in an international environment and are you prepared to embrace and tackle challenges as part of your work each day? Are you structured, with excellent planning skills and a mind-set for optimisations? Do you enjoy communicating across boundaries and with different functions? If you answer yes to all questions, we may have just the right job for you. We are now looking for a Clinical Trial Administrator (CTA) to join the team. Come be part of our team as we embark on an exciting journey of growth! Bring your clinical expertise to change lives of millions. The Position In this role, you will provide clinical trial administration support to the Study Start-up team, as well as the Danish team, with the support of a centralised CTA community. Your main stakeholders in the role are Trial Start-up managers and specialists, submission- and feasibility specialists, CRAs and Trial Managers involved in assigned clinical trials. In detail you will: · Primary support to the Study Start-up team, that consists of submission-, start-up- and feasibility specialists. Here you will be the primary CTA to provide cross-trial as well as trial-specific support, mainly during study start-up activities, such as: · Set up and maintenance of clinical IT systems, Trial Master File, communication structures · Preparation of trial specific documents, and handle contracts in relevant systems and follow up on timely signature · Ensure trial management readiness for Clinical Trial Application submissions to Health Authorities and Ethics Committees In addition, you’ll be providing support in the execution and finalisation of trials to facilitate the process towards timely clinical trial deliverables of required quality and to ensure oversight of trial documentation for assigned clinical trials, covering all involved affiliates within Clinical Development Centre (CDC) DK. Finally, we expect you to be an active member in the CDC-DK CTA community ensuring alignment and providing ongoing optimisation of systems and processes. Qualifications We are looking for an engaged and dedicated colleague and as a minimum we expect you to: · Hold a bachelor’s Degree or equivalent experience · Be an experienced administrative employee that enjoys being busy, variety and multitasking · Bring strong problem-solving skills, a can-do attitude and the ability to prioritise tasks. We expect you to be energetic and positive for changes and thrive in an environment where not two days are alike · Experience in clinical research and the start-up activities or knowledge of the clinical trials environment – ICH GCP, regulatory issues, SOPs is an advantage · Be fluent in Danish and proficient in English (verbal and written): We work in Veeva Vault, Trial Master File and CTMS but it is not a requisite to have experience within the systems as long as you have a proven record of being curious to learn and explore IT systems About the Department As the Clinical Trial Administrator, you will be part of the Study Start-up team that consist of a mixed group of specialists in start-up activities, reporting to the head of study start-up. We are located in Copenhagen, Ørestad, including a couple of virtual colleagues. The Clinical Development Centre Denmark is one of the biggest clinical organisations within Novo Nordisk Northwest Europe. We are currently evolving as we are entering new therapy areas and broadening our portfolio of the clinical trials. CDC Denmark as project-centric organisation becomes the backbone in clinical trials for all Therapy Areas, while leading across seven countries, as well as Denmark. Together with our colleagues across the value chain in Head Quarter (HQ) and adjacent affiliates, we ensure through scientific evidence that we can provide safe and efficacious treatment to people living with diabetes and other chronic diseases. We value an open, trust-based, and creative working environment as well as a great team spirit. Our working environment is characterised by interesting and demanding assignments and continuous professional development opportunities. 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, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact If you have any questions, please contact Hanne Verstraete, Head of Study Start-up, at +32 490 56 84 81 ǀ [email protected]. Deadline Apply before 25th March 2024. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ørestad.
Jobbet er oprettet på vores service den 18.3.2024, 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.
- Forretningsudvikler
- Ørestad
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