Description
Primary Responsibilities:- Accountable for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budgets
- Responsible for Phase I Unit site selection / CRO vendor management and oversight
- Independently lead cross-functional early phase CRO / study teams (facilitate study team-CRO communication across various internal science, clinical, operational and technical functions)
- Provide input to the program budget and is accountable for managing overall study budget
- Conduct protocol and site feasibility assessments
- Provide drug supply assumptions to clinical planning team
- Provide support, mentoring, and study-specific training to Clinical Operations staff
Skills / Experience:
- 6-8+ years study management experience in clinical and drug development, including managing and partnering with Early Phase CRO's to deliver a broad range of CRO services
- Highly experienced in managing early development phase clinical studies and experienced in clinical research/development
- Effective leadership of multiple cross-functional study teams
- Demonstrated experience in various therapeutic areas; experience in conducting healthy volunteer ClinPharm or Phase I dose escalation studies
- Excellent planning, delegation, and organizational skills
- Familiar with global trial requirements
- Highly effective verbal and written communication skills in English
- Working knowledge of international regulatory and ICH GCP guidelines
Education: Bachelors degree or equivalent required (scientific or healthcare discipline preferred)
To find out more about Real please visit www.realstaffing.com