Senior Clinical Trial Scientist 100%
12-month contract based in Basel area.
The Senior Clinical Trial Scientist is representing clinical science as core member of the Clinical Trial Team and contributes to the following trial-level activities:
Main Responsibilities:
* Collaborates closely with the Clinical Trial Physician (CTP) 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, study committee charters, study guidelines/instructions, PD code list, subject narratives, and the CSR.
* Provides input into and reviews cross-functional trial documents such as the SAP, ESP 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 and HAs.
* 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 5 years of working experience preferably in clinical development in a contract research organization (CRO) or pharmaceutical company. Monitoring experience is an advantage;
* Experience in working in cross-functional environment. Able to coordinate cross-functional activities.
* 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.
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.
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