Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field
Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes
Experience with CROs and outsourced clinical trial activities, sponsor experience preferred
Solid knowledge of drug development and clinical trial processes, including related standards and documents
Experience in clinical trials systems management and oversight (Veeva preferred)
Proven awareness of sponsor oversight requirements and regulations
Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
Strong project management and communications skills to effectively assess risks, establish priorities, take initiative, and meet deadlines
Must be able to work in a fast-paced, changing environment with demonstrated ability to prioritize multiple competing tasks and demands
Solid knowledge of regulatory requirements governing clinical trials and industry best practices
Bachelor's degree preferred or commensurate with experience
Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations