Would you like a challenging and varied job in an active work environment within Product Development Denmark (Clinical Operations)? As a Study Start Up Specialist (SSUS) you will be responsible for the management of Informed Consent Forms (ICF) and submission of clinical trials to the authorities. You will have a close collaboration with Authorities and various global and local functions related to Product Development. Product Development in Denmark has 37 employees. You will be part of the Business Support Team consisting of 10 dedicated colleagues, you will report to the Business Support Leader.

Following qualifications are required:
You have a healthcare professional/scientific background and experience in the pharmaceutical industry.

We expect you to have:

• Experience with submissions of clinical trials to the Danish Medicines Agency and Ethical Committees. Further, it is an advantage if you have experience with medical devices and clinical trials.
• Experience with ICH/GCP and an understanding of clinical development in an international environment
• Strong communication skills, and you master Danish and English in both speech and writing
• The ability to work structured and organized, including the ability to prioritize and handle different tasks within a short deadline
• The ability to combine integrity, courage and passion with a flexible approach to problem solving
• A winning personality with a high engagement and the ability to work in a self-managed team in an agile organization

Following areas of responsibility will be assigned to you:

• Accountable for ICF (Informed Consent Form) management and other required documents to the Ethical Committee
• Submission of clinical trials and amendments to the Ethical Committee and Danish Medicines Agency
• Support activities in relation to questions from local and global study teams and Authorities
• Use and update systems like Clinical Trial Management System
• You will collaborate closely with the Study Start Up group and Country Study Managers
• You will collaborate locally with the preparation of quality checks, audits and inspections

We place special emphasis on the following competencies:

• Communicating information (Convincing people, Articulating information, Challenging ideas)
• Structuring tasks (Developing expertise, Adopting practical approaches, Providing insights)
• Building Relationships (Interacting with people, Establishing rapport, Impressing people)
• Driving Success (Taking action seizing opportunities, Pursuing goals)

You will have excellent possibilities for both your personal and professional development in a dynamic and changeable organization, to which we are committed to developing our employees. With the job comes a competitive salary, telephone, bonus, PFA pension and various health insurances.

Please feel free contact Business Support Leader Manager Mette Bech Clausen at +45 24 88 60 00 for further information about the position.

Please send your application no later than June 20, 2021. Please note that only applications submitted through our recruitment system will be taken into consideration.

About Roche
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed more than 93,700 people worldwide. In 2018, Roche invested CHF 10.3 billion in R&D and posted sales of CHF 56,8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

About Roche in Denmark
Roche Pharmaceuticals is the Danish affiliate of the Roche Group. We have just gone through an agile transformation and are establishing an operating model based on flat hierarchy, agile ways of working with people empowered to contribute to our North Star: “Better Outcome for More Patients Faster”. Roche Pharmaceuticals employs approximately 120 employees. We have 2 sister companies in Denmark: Roche Diagnostics in our building and Roche Innovation Center Copenhagen, situated north of Copenhagen. Roche a/s is the leading company in Denmark within cancer treatment.