Social network you want to login/join with:
Responsibilities:
* Collaborates closely with the Clinical Project Scientist or Clinical Trial Physician on relevant trial-related activities
* Develops a sound understanding of the science and medicine related to an indication and trial and performs literature searches as needed to keep knowledge up to date
* Main deliverables include the clinical trial protocol and related documents such as the ICF, trial committee charters, trial guidelines/instructions, PD code list, participant narratives, and the CSR
* Provides input into and reviews cross-functional trial documents such as the SAP, external service provider requirements and specifications, monitoring guidelines, data review manual
* Performs data review and medical monitoring during the conduct of the trial
* Coordinates/manages the study committees
* Provides scientific input into responses for IRBs/ECs, HAs, sites and monitors
* Participates in discussions with external experts
* Trains the relevant functions and roles on the scientific aspects of the trial
* Contributes to cross-functional and clinical development initiatives and processes as needed
Qualifications and Experience:
* Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required.
* PhD, Pharm D, MSc or equivalent university degree in life or health sciences
* At least 4 years of working experience preferably in clinical development in a contract research organization (CRO) or pharmaceutical company. Monitoring experience is an advantage
* Experience in the planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific and operational perspective
* Previous authoring/co-authoring of clinical trial protocols, ICFs, scientific trial-related documents (e.g., trial committee charters) is an advantage
* Previous experience in the Therapeutic area of Cardiovascular, Renal and/or Central Nervous System Diseases is an advantage
* Good knowledge of drug development and clinical trial process
* Good knowledge of regulatory requirements/ICH guidelines
* 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
If you'd like to learn more about CTC and the outlined opportunity, please contact us using the 'apply now' button or by emailing [emailprotected].
#J-18808-Ljbffr