Clinical Development Scientist (136) Sourcing

Industry :  Pharmaceuticals

Title :  Clinical Development Scientist

Location : Cambridge, MA

Duration : 12 months contract ( Chances of extension)

Overview :

We are seeking an experienced  Clinical Development Scientist  to join our team as we continue to advance rare disease medicines for cholestatic liver disease into clinical development. In this position, you will be an integral part of the clinical development team supporting the execution of early phase clinical studies. The ideal candidate will have outstanding communication skills, attention to detail, and the ability to thrive independently in a highly innovative and fast paced environment.

Job Responsibilities

• Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, efficacy, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, site initiation visits, advisory boards)
• Partners with the medical monitor and / or other clinical scientists on oversight of clinical trial activities, including safety reviews and site interactions
• Extensive experience cleaning study data
• Liaise with the broader clinical development team (clinical operations, data management, and regulatory teams)
• Contribute to authoring key study and regulatory documents (e.g. protocol, ICF, study manuals, briefing books)
• Leads internal meetings to review topics and develop mitigation plans
• Contribute to the development of presentations, abstracts, and publications emerging from clinical and translational studies
• Collaborate with clinical and research teams to implement the clinical biomarker strategy for early phase clinical studies
• Ensure compliance of all activities with ICH / GCP guidelines, applicable regulatory requirements, and SOPs
• Other duties as assigned

Qualifications

3 years of clinical development experience in an industry setting

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