Clinical Trial Supply Specialist
Driven by research and a passion for science Ferring Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative treatments that make a real difference in people’s lives all over the world. Active in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopedics, we develop medicine on the body's own terms. We believe in the power of people and research - and go where ideas and research take us.
Would you like to join us in a challenging position as Clinical Trial Supplies Specialist we offer a challenging and exciting job in an international company with great development possibilities, an entrepreneurial and open work environment, where your contributions will be valuable and make a difference.
The Clinical Trial Supply Department is responsible for packaging, distribution and IRT (Interactive Response Technology) set up for the clinical trials conducted worldwide. Parts of the packaging and distribution is handled in close collaboration with different vendors.
The position is placed in our department within the Global Pharmaceutical Research & Development group and you will be part of a dynamic team in a stimulating international environment located in Ørestad, Copenhagen.
Your main focus is to drive the study specific IRT set up within the organization and continuous process improvements.
On a trial level you will be responsible for
- Clarification of IRT demand and plan implementations
- Developing URS, preparing UAT incl. test planning, executing UAT and writing test reports
- Reviewing the clinical trial protocols from an IRT perspective
- Maintaining IRT related documents e.g. Validation plan and Risk assessment
- Giving input to forecast and budget
- Coordination between involved stakeholders on a trial level, and establish and maintain contact with CMOs on a trial and strategic level
- Support and maintain clinical trial supply related IT systems and processes
- Drive continuous improvements initiatives related to CTS processes
- Keeping relevant SOPs updated
- Working according to GMP, GDP, GCP, SOPs and internal safety regulations
We expect you to hold a Masters degree in Pharmacy or equivalent and have hands on experience with setting up IRT systems for clinical trials. Other experience with the Pharmaceutical industry and understanding of GMP and GCP requirements for clinical trial supply would be an advantage. A wish to work in an international multicultural corporate environment is desirable.
Strong communication skills are essential in this role that has interactions with many other disciplines. You have the ability to work independently and as part of a team, and you are proactive and service-minded. You must also have strong analytical, problem-solving and organizational skills. You are fluent in English and keen on working in a multicultural environment.
For additional information, please contact Marianne Søndergaard, Director, Clinical Trial Supply, Global Pharmaceutical R&D on +45 2878 7788.
Please send your application and CV in English as soon as possible but no later than 4 November 2016, as we will review incoming applications on an ongoing basis.