Senior Clinical Trial Scientist
Senior Clinical Trial Scientist - (160000HO)
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 Senior Clinical Trial Scientist, based in Allschwil.
This is an opportunity to participate in or lead the entire range of scientific responsibilities at the trial level, for compounds in phases II and III of development, across multiple therapeutic areas.
- Develop a sound understanding of the science and medicine related to a trial, including competitive landscape
- Perform literature reviews
- Accountability for the Clinical Science trial-related Protocol, incl. amendments and the Clinical Study Report (CSR)
- Responsibility (under the accountability of the CTP) for delivering Subjects' narratives and Core Informed Consent Form (CICF)
- Responsible for the review of the following documents generated by other departments: Data Review Manual, Statistical Analysis Plan (SAP), Dummy tables, Case Report Form (design, completion), External Service Providers' (ESP) user requirements and data transfer specifications (DTS), Review of medical coding
- Is accountable for the following trial-related activities: Scientific training of the Clinical Trial Team (CTT) members, Steering Committee (SC) management (including charter), Independent data monitoring committee (IDMC) management (including charter, excluding medical monitoring), Event Committee management (including charter), PD management, Review of non-medical coding, Filing of CS trial documentation
- Is responsible, under the accountability of the CTP for Medical monitoring and Data interpretation.
PhD, Pharm D, DVM, MSc or equivalent degree in Biological Sciences
At least 3-5 years' experience in clinical research in a clinical research organization (CRO) or Pharmaceutical Company
The following clinical trial-related experience is required:
Contributed to all key phases of trial (set up, run, closure)
Previous co-authoring of: ICF, protocol, narrative
Previous involvement with and able to define: protocol deviations (PD), CRF specifications, medical monitoring, CS input to trial-related guidelines/instructions and SAP elaboration
Previous involvement in study design discussion (e.g., outline elaboration, amendment, CDP, discussion with external experts)
Good understanding of other departments' process and needs at trial level
Good knowledge of drug development and clinical trial process based on previous deliverables
Good knowledge of regulatory requirements/ICH guidelines
Excellent organisational and problem solving skills, interpersonal skills with the ability to work under pressure and meet short timelines
Inspires and convinces others, gaining agreement from people, lobbies and networks effectively with key stakeholders
Demonstrated ability to work independently in a fast-paced environment, to prioritize multiple competing tasks, to proactively address issues and demands
Fluent in written and spoken English.
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
Job Type: Standard
Job Posting: Sep 21, 2016