CAREER SUMMARY A certified clinical research professional with over 25 years experience and extensive knowledge of federal regulations and ICH Good Clinical Practice (GCP) guidelines as applied to clinical trials. Responsibilities have included development and revision of policies and procedures for clinical and regulatory operations, supervision of clinical staff, maintenance of operational and financial targets for key clinical trials, clinical research organization (CRO) and/or investigator assessment and selection, negotiation of budgets and oversight of the conduct of clinical trials to ensure quality and integrity of data as well as safety and efficacy of the compound. Continued growth and success has been afforded by critical reasoning skills including the identification and resolution of complex problems, the ability to coordinate multiple tasks, a clear understanding of the drug development process, an eagerness to meet new challenges, and most importantly, commitment to excellence. ATTRIBUTES Excellent communication skills, both verbal and written effective teamwork through coaching and mentoring valuable interpersonal skills high level of initiative ability to work independently as well as collaboratively on project teams ability to interface with CROs and investigative sites ability to identify safety and efficacy data trends computer literacy.

Highlights:

• Cardiovascular
• Oncology
• Ophthalmology
• Research
• Urology
• Data Management
• Management
• Audit
• Compliance