Seasoned director of clinical operations and project management with over 18 years of experience in local and global CRO and pharmaceutical industry, strong background in site start-up, site activation, phase I, BA/BE, phase II -IV. Managing projects from 500k to 350M. * Expert in planning, execution, organizing, and managing resources to successfully deliver highest quality completed projects while managing and honoring set constraints management with CROs/clinical vendors and vendor and site audits. * Authored SOPs, work in business development, site selection, website design, and developed working relationships with Sponsors and Key Opinion Leaders. * 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. * Supported each clinical team in creation of a study plan for both timelines and budget with documentation of assumptions/expectations within Microsoft Project. * Effectively communicated project status to project stakeholders documenting within Trial Master File (TMF) system. * Specialize in Site Assessment - start up, contract and budget negotiation, Standard Operation Procedures, identify possible risk areas and implement solutions, audit site SOP and data. * Background includes trials in the following areas: Neurology, Ophthalmology, Urology, Oncology, Dermatology, CNS, Medical Device, Generic Drug, BA/BE Phase I, Women's Health and Healthy Volunteer Trials. * Well versed in FDA/ICH, IRB/EC Submissions, GCP, 21 CRF part 11, CLIA, OSHA and HIPPA regulations. Re-established open and working relationships with Proctor & Gamble and Merck Pharmaceutical, negotiated contracts lost by prior upper management. Arranged, coordinated and led meeting with an outcome of a five-year, $200 million contract with P&G. * Reorganized and implemented new budgeting process improved net by $1 million. * Implementation of new incentives for the staff that helped boost morale, 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 revenue of $500k within the first six months after the opening of a new research department.

Highlights:

• Research
• Clinical Research
• Training
• Support
• Outsourcing
• Clinical Management
• Documentation
• Management
• Planning
• Policies and Procedures