Study Start-up Specialist (Maternity cover)
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Ørestad
Do you want to be part of a dynamic team driving clinical start-up activities in Denmark? Would you like to use your experience to continuously optimise the way trials are launched? Are you prepared to embrace and tackle challenges as part of your daily work? If your answer to these questions is ‘yes’, read on. We are now looking for a Start-up Specialist to join us on a temporary basis (1 year maternity cover) within Clinical Development Centre in Denmark! 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 be driving local start-up activities (from feasibility to FPFV) in the allocated clinical trials in Denmark (DK) in compliance with local/global regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements, to deliver reliable, high-quality data and study subject recruitment and retention. You will be responsible for ensuring timely study start-up and site activation, including involvement in local feasibility, contracting and other start-up activities. In detail you will: Lead local feasibility process in accordance with central patient allocation process; obtain data supporting feasibility assessments, lead site identification process and develop new sites, including KOL and investigator involvement, build and maintain sound knowledge of local patient pathways and clinical research environment, in close collaboration with the CDC DK Feasibility specialist, clinical medical manager (CMM), local medical team and head of Therapeutic Area.
Manage commercial and contractual relationship with investigators and clinical sites to meet timelines and demands of assigned clinical trials; negotiate contract language and budget with sites, manage contract issues and liaise with Legal, Clinical teams, and other internal and external stakeholders to resolve such issues.
Own and coordinate local start-up activities ensuring timely submission and FPFV, proactively flagging risks and issues and providing possible mitigations and solutions. Liaise with relevant internal stakeholders (CRA, Trial managers, CTAs, …) to agree on start-up strategy and lead and provide direction to the local trial team to ensure successful trial start-up in a high-quality manner.
Qualifications The start-up specialist position requires excellent organizational, communication and negotiation skills, as well as a strong understanding of the clinical trial process. In addition, you have: Experience from similar role in the pharmaceutical industry or Clinical Research Organisation (CRO).
A degree within life science or healthcare
Experience in feasibility, contracting and clinical start-up on role of CRA or trial manager (Pharmaceutical industry or CRO).
Fluent level of written and spoken English and Danish.
Ability to work independently while also being a dedicated team player
Strong problem-solving skills, a can-do attitude and the ability to prioritise tasks
About the Department As the start-up specialist, you will belong to a team that consist of a mixed group of specialists in start-up activities, reporting to the head of study start-up. 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 20th February 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 7.2.2024, 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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