Responsibilities
- Leads the Clinical Study Team for assigned projects; may lead one or more clinical studies, from concept to protocol, and achieve corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc.
- Manage external vendors and contract research organizations, may manage internal resources such as Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)
- Prepare/Review/Approve study documents such as the Monitoring Manual, Study Operational Manual, Source Data Verifications Plan, and Laboratory Manual
- Coordinate and design study materials such as CRFs, patient diaries, study participation cards, and source documents.
- Manage operational activities at the study level and monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to GCP, Standard Operating Procedures (SOPs), and study protocols
- Negotiate and mange vendor work agreements an site contracts
Requirements
- Bachelor’s degree in a scientific discipline or equivalent is required, and an advanced degree
- Requires at least eight years of biopharma industry experience (relevant clinical trials experience, in the biotechnology, pharmaceutical, CRO, medical device industry) with at least two years managing clinical trials
- Must have vendor management experience in clinical operations/development
- Strong verbal and written communication skills, can communicate strategic direction and relevant context so that employees at all levels understand their role in achieving success
- Ability to build and maintain strong working relationships within the department and cross- functionally to meet a project or corporate goal
- Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook)
- Must be able and willing to travel periodically
Work Arrangement
Hybrid
Additional Information
- Must be able and willing to travel periodically
