Global Trial Leader
Global Trial Leader - ( 160000IG )
About the Company
Actelion Pharmaceuticals Ltd. is a leading biopharmaceutical company employing over 2,500 dedicated professionals covering all key markets around the world – including Europe, the US, Japan, China, Russia and Mexico. Headquartered in Allschwil, near Basel, Switzerland, our functional, award-winning Actelion Center is a symbol of our innovative spirit and culture.
We are searching for breakthrough medicines for high unmet medical needs and this inspires and motivates all of us to work towards achieving our overriding mission: to treat more patients with groundbreaking therapies.
Besides highly competitive compensation and tangible benefits, would you like to have a noticeable impact and enjoy our culture of innovation, trust and teamwork? Do you want to grow in a different kind of company with an enthusiastic, stimulating environment fostered by open communication and a results-driven approach? Then we welcome your application to join our team in the role of Global Trial Leader, based in Allschwil.
- Leading and providing direction to the global cross-functional Clinical Trial Team to ensure all trial output from protocol development to final clinical study report (including archiving of the (e)Trial Master File) are delivered on time, within budget, and with highest achievable quality
- Developing, updating, and ensuring adherence to agreed upon global trial budget
- Representing the Clinical Trial Team at Clinical Project Team meetings
- Chairing Clinical Trial Team meetings and ensure timely follow up of agreed upon actions
- Ensuring adequate trial resources in personnel and material cross-functionally
- Creating, maintaining, and updating the Clinical Trial Plan
- Coordinating the development of trial-related core documents, such as the protocol, site guidelines, data management plan, statistical analysis plan, and clinical study report
- Coordinating the development of specifications for external service providers in collaboration with Global Clinical Outsourcing and the Clinical Trial Team and ensure appropriate quality control of deliverables
- Leading trial-related external meetings, e.g. Investigator meetings
- Providing regular trial status updates (including critical issues and key performance indicators) and resolving issues at the Clinical Trial Team level in a proactive and timely fashion
- Escalating unresolved issues
- Coordinating pre-audit activities ensuring satisfactory outcome
- Implementing best practices and lessons learned and share outcome with the teams
- Assuming responsibility for other project or trial-related duties as assigned.
- Master’s degree or equivalent university education/degree in life sciences or healthcare
- Minimum of 7 years relevant experience in clinical development and clinical trial management
- Fluent in English; fluency in other languages is advantageous
- Demonstrated expertise in global clinical research and development and project management (including risk management and contingency planning)
- Advanced knowledge of International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines and other relevant clinical trial regulations
- Demonstrated experience and leadership skills (e.g., leading project teams) working in global cross-functional (matrix) and multi-cultural teams
- Experience in managing complex studies (e.g., large Phase III studies, difficult patient populations, external service providers)
- Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)
- Experience selecting and managing external service providers
- Good understanding of clinical trial budget/resource forecasting and management
- Ability and willingness to travel internationally.
What Actelion Offers
- A competitive salary and generous social benefits
- The possibility for development and advancement within our dynamic organization
- The innovative and stimulating atmosphere of a multicultural environment
The research facilities are located in Allschwil, Switzerland, a suburb of Basel on the borders of France and Germany.
Primary Location : CH-BL-Allschwil
Job : Clinical Development
Schedule : Full-time
Job Type : Standard
Job Posting : Oct 10, 2016