Efficient, effective, focused, insightful, results-oriented leader with clinical, operational, financial and people management skills. Over 20 years of strategic involvement in clinical research including development of Clinical Affairs Department at a publicly traded Medical Device Sponsor Company. Consistently demonstrates strong planning, management, leadership and interpersonal skills.FDA Experience: IDE PMA, FDA Sponsor and Site Audits with no findings, FDA Pre-Sub & Q-Sub Meeting experience, Author of Annual FDA Reports and Safety Reports.
Listed skills include Program Management, Project Management, Clinical Research, Management, and 17 others.