Clinical Operations Leader & Trial Manager
24+ years executing, monitoring, and controlling clinical trial operations. Leverages leadership, process, and technical expertise to administer patient trials with passion, integrity, and care while achieving corporate deliverables and financial goals. Collaborative and high-performing clinical operations leader with expertise in the strategic and operational oversight of Phase I-III trials.
Relevant Therapeutic Areas
- Infectious Disease
- Metabolic Disease
- Director, Clinical Operations
- Manager, Clinical Operations
- Open to remote and travel
- Small & Medium Sized Biotechs
Skills & Accomplishments
- Responsible for vendor engagement and oversight, maintaining frequent contact and oversight of CRO to assess performance and provide guidance as needed.
- Oversee clinical study sites’ adherence to pertinent regulations.
- Responsible for the selection of investigational sites.
- Participated in selection and implementation of eTMF system.
- Responsible for creating, approving, and implementing key SOP’s.
- Responsible for developing strategic recruitment plans, milestone reporting, issue and risk identification, analysis and mitigation/containment and fiscal maintenance.