Clinical Scientist
il y a 3 jours
**Responsibilities**:
- Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards)
- Partner with the study lead on oversight of clinical trial activities, including safety reviews and site interactions
- Liaise with the broader clinical development team (clinical operations, data management, statistics/programming, and regulatory teams)
- Contribute to authoring key study and regulatory documents (e.g. protocol, ICF, study manuals, briefing books)
- Lead internal meetings to review topics and develop mitigation plans
- Contribute to the development of presentations, abstracts, and publications emerging from clinical studies
- Ensure compliance of all activities with ICH/GCP guidelines, applicable regulatory requirements, and Ipsen SOPs
- Other duties as assigned
**Qualifications**
- Advanced degree in life sciences (PhD, MD, or PharmD)
- 3+ years of clinical development experience in an industry setting
- Experience with the development of key clinical study documents
- Experience with the analysis and review of clinical data
- Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
- Track record of working with and managing CROs and external vendors
- Strong attention to detail and organizational skills
- Exceptional verbal and written communication skills
- Ability to build strong relationships and work effectively with cross-functional teams
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