Clinical Operations Leader & Project Manager
Over 10 years of clinical research experience managing industry-sponsored studies across multiple therapeutic areas. Proven track record for ensuring compliance with government regulations such as FDA, TGA, PEI, CBER, EMA, and MHRA through meticulous auditing and quality control. Expertise in implementing global expanded access programs. Demonstrated leadership abilities that are key in providing innovative and efficient solutions in the evolving clinical research space.
Relevant Therapeutic Areas
- Rare Disease
- Expanded Access/Compassionate Use
- Senior Director, Clinical Operations
- Director, Clinical Trial Operations & Monitoring
- Open to remote and travel
- Small & Medium Sized Biotechs
Skills & Accomplishments
- Vendor selection and management, budget negotiation, and oversight of start-up activities.
- Inspection readiness activities for NDA submissions for global programs across therapeutic areas.
- Has held several director level positions at mainly small companies and is consequently very hands-on, cross-functional, and a team player.