Summary Seasoned director of clinical operation and project management with over 18 years' experience in local and global CRO and pharmaceutical industry, specializing in phase I, BA/BE start-up operations. Complete and solid understanding of business priorities, genuine team player committed to managing operations and projects efficiently and without flaws, while contributing to revenue producing activities. Serve as a key point of contact for clients and vendors, cross functional communicators easily interface with high-profile staff. Coordinating and implementing research and administrative strategies essential to the successful management of Phase I-IV clinical research trials, site and study management, program, and project management for a full service clinical trial management / global CRO. Specialize in Site Assessment start up, contract and budget negotiation, Standard Operation Procedure, identifying possible risk areas and implementing solutions. My background experience includes trials in the following areas neurology, ophthalmology, urology, oncology and women's health and healthy volunteer trials. But specialize in Neurology and Ophthalmology therapy. Well versed in FDA/ICH, GCP, CLIA, OSHA and HIPPA regulations Accomplishments * Re-established open and working relationships with Proctor and Gamble and Merck Pharmaceutical to negotiate contracts lost by prior upper management. Arranged, Coordinated and lead meeting with an outcome of a five-year, 200 million-dollar contracts * Reorganized and implemented new budgeting process and created a positive revenue of over 1 million dollars * Implementation of new incentives for the staff that helped boosts morale and increased productivity by 27% and created a positive workplace environment * Created a clinical research department for inpatient and outpatient trials in conjunction with one of the local hospitals * Generated positive revenue of 500k after the opening of the research department within the first six months Accomplishments * Re-established open and working relationships with Proctor and Gamble and Merck Pharmaceutical to negotiate contracts lost by prior upper management. Arranged, Coordinated and lead meeting with an outcome of a five-year, 200 million-dollar contracts * Reorganized and implemented new budgeting process and created a positive revenue of over 1 million dollars * Implementation of new incentives for the staff that helped boosts morale and increased productivity by 27% and created a positive workplace environment * Created a clinical research department for inpatient and outpatient trials in conjunction with one of the local hospitals * Generated positive revenue of 500k after the opening of the research department within the first six months

Highlights:

• Clinical Research
• Research
• Dermatology
• Support
• Clinical Management
• Documentation
• Management
• Ophthalmology
• Outsourcing
• Cardiology