Senior International Trial Manager for Global Development Biopharm

Do you have experience working with clinical trial management within the pharmaceutical industry and do you want to be part of a dynamic team that drives the clinical trial activities in our Biopharm area? Then we may have the right job for you.

In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. We ensure medical and scientific documentation for clinical submissions and authorities while ensuring that the process lives up to uniform global standards, regulations and business ethics. We work in global project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society.

About the department
Biopharm Trial Operations consists of approximately 75 highly skilled and ambitious colleagues responsible for planning and execution of clinical trial activities within haemophilia, rare bleeding disorders and growth disorders. The scope of our activities is phase 1 to 4 clinical trials and non-interventional studies in collaboration with external vendors, internal project stakeholders, and our Novo Nordisk affiliates worldwide.

You will join a department consisting of 18 dedicated colleagues collaborating on lifecycle management activities for marketed products within haemophilia and rare bleeding disorders, as well as development of new treatments entering clinical development. Our environment is characterised by a large global network with challenging assignments in a project centric organisation. We focus on continuous personal and professional development and offer exciting opportunities for cross-organisational collaboration and future career development.

We value an open, trust-based and creative working environment, great team spirit and a high quality mind-set. Our working environment is characterised by interesting and demanding assignments, we often need to develop new solutions in an ever-changing regulatory and highly competitive clinical trial environment.

The position
As Senior International Trial Manager, you will be responsible for leading a clinical trial ensuring timely planning, execution and finalisation. You will lead the International Study Group and ensure coordination of trial management activities in a proactive way through clear communication and teamwork skills. Organising and executing team meetings as well as planning, preparing and presenting at global investigator and monitor meetings are also part of your responsibilities.

You have a structured and analytical approach as well as a high quality mind-set when developing trial documents such as protocols, monitoring guidelines, recruitment/retention strategies, risk management plans and communication plans etc. You are capable of and enjoy guiding and collaborating with less experienced trial management staff.

You sense the importance of detail when setting up a trial and providing input to clinical IT systems. At the same time you are able to digest complex data output and evaluate the level of data quality during a trial using our established processes. You are able to ensure progress of trial activities within given timelines and in accordance with the trial budget prepared by you.

Qualifications
You hold a university degree in natural science or equivalent with minimum five years of experience in trial management and clinical development methodology. You have solid project management/leadership skills and work in an independent manner.

You must have the drive and focus to meet challenging deadlines and know how to prioritise between different tasks in a dynamic environment. You are a dedicated team player with a high degree of flexibility and cross-cultural awareness who inspires trust amongst colleagues and external partners. Proficiency in written and spoken English is essential.

Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact
For further information, please contact Susanne Møller Nissen at +45 3075 6195.

Deadline
1 March 2018.


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