Clinical Project Leader, Global Clinical Operations
Ferring Pharmaceuticals A/S, Copenhagen, Denmark
Research and Development, Denmark.
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 fertility, obstetrics, urology, gastroenterology, hepatology, 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.
As Clinical Project Leader (CPL) you are part of the Global Clinical Operations team, currently consisting of approx. 50 experienced and highly dedicated persons (CPLs, Trial Managers, Document Managers and a Clinical Project Coordinator).
The CPL is representing Global Clinical Operations as core member of the Global Project teams. The CPL is responsible for delivering tactical and strategic input to the development plans and ensure the most appropriate clinical program is planned and conducted. The CPL works closely with the global project teams, therapeutic area functions, medical writing and trial management teams to deliver excellent clinical results to plan. The successful CPL will be the trusted clinical expert, be efficient in stakeholder management, develop and ensure project standards, and be confident in working with empowered trial teams. In addition, the CPL is expected to support further development of the CPL role globally in Ferring.
You will be accountable for the delivery of agreed clinical projects. Your essential tasks will be to:
- Collaborate with relevant stakeholders for preparation of Clinical Development Plans to facilitate timely identification and planning of clinical programs and to provide operational input on behalf of Global Clinical Operations
- Ensure the overall delivery of clinical trials according to agreed project strategy, timelines and budget
- Proactively identify project risks, provide input to risk mitigation and contingency plans and ensure implementation of action plans to reduce or eliminate project risks
- Collaborate across clinical operations teams globally for the assigned clinical project to ensure alignment with agreed strategy and project standards
- Provide clinical input to the regulatory strategy including implications on costs, resources and overall timelines
- Review and provide operational input to clinical documents related to the drug development process including Investigator Brochures, Clinical Trial Outlines and Protocols, Clinical Trial Reports and relevant correspondence with regulatory agencies
- Ensure development and management of trial budgets, availability of internal resources, and ensure regular updates of external costs and resources in planning system
- Interact, build and maintain relationships with key internal functions and external stakeholders such as e.g. project directors, experts and key opinion leaders
We expect you to have a Master degree within medicine or life sciences, extensive experience within clinical drug development from a similar role and preferably at least 5 years’ experience in managing clinical trials as a senior trial manager. You have experience with multi-country and multi-center trials and phenomenal project leadership skills.
You are motivated by having a high impact position and understand how to apply your clinical development expertise to create excellent and lean clinical programs, and you can inspire trust and respect among your international colleagues. You are energetic, positive and have a strong can-do-attitude.
The successful candidate is ambitious with an easy yet assertive personality. We expect you to be a true team player, able to navigate in a complex environment and to work independently and with authority. Clinical trial experience within Hepatology & Gastroenterology and/or Urology is an advantage.
You will need to have a tactical and strategic mindset with high quality standards. In addition, it is essential that you are well organized, pro-active and flexible with the ability to work on multiple tasks in a multicultural environment.
Excellent knowledge of MS Office and fluency in English with good verbal and written communication skills is a given.
For additional information, please contact Vice President Anne Louise Kjølbye via AnneLouise.Kjoelbye@ferring.com. Please send your application and CV in English via the application button as soon as possible but no later than 6 April 2018. We will review incoming applications on an ongoing basis. Please click here to apply.
Vice President Anne Louise Kjølbye via AnneLouise.Kjoelbye@ferring.comAll Vacancies