Provide leadership, mentoring and guidance to the clinical and cross-functional departments through sound clinical, regulatory and quality judgement and effective communication. Lead interactions with clients, stakeholders and regulatory authorities. Responsible for the overall execution of clinical trials by establishing goals and culture of a supportive rewording work environment, while providing high quality services and deliverables to our clients.

Provided project management for sponsor companies, specifically in the medical device and diagnostic arena. Responsible for full execution of clinical programs, including compliance with regulations and trial specifics, quality assurance, contracts and budgets, vendor management, staffing/resourcing to each project, ensure proper training of the clinical team, data integrity, review of safety issues and project reports to sponsor companies.

Responsible for the implementation, oversight and management of multiple US and international clinical studies for products treating a variety of indications such as: asthma, migraines, COPD, sinusitis, anxiety and depression. Responsibilities include the preparation and approval of regulatory submissions, overseeing data management, safety reporting, training of investigators/sites and CRO’s, monitoring/auditing, while supporting product development and marketing initiatives.

Provided clinical trial support and management for clients of this specialty clinical research organization, from regulatory to clinical services, including study trial design and development. Worked in a partnership with each client (U.S., Brazil, Mexico, Europe and Canada) to ensure study objectives, timelines, deliverables, and financial expectations were met. Facilitated effective communication among all project-related members, contractors and vendors.

Held a number of increasingly responsible positions at this specialty medical device company, including being promoted to oversee the complete operation of the Clinical & Regulatory Department, reporting directly to the President & CEO. Responsible for three pivotal multicenter double-blind placebo-controlled studies conducted in the U.S. Responsibilities also included site selection, study/ site initiation, monitoring, study closures and supervising in-house monitors. Responsibilities… Show more Held a number of increasingly responsible positions at this specialty medical device company, including being promoted to oversee the complete operation of the Clinical & Regulatory Department, reporting directly to the President & CEO. Responsible for three pivotal multicenter double-blind placebo-controlled studies conducted in the U.S. Responsibilities also included site selection, study/ site initiation, monitoring, study closures and supervising in-house monitors. Responsibilities included budgeting, staffing, establishment of and adherence to Standard Operating Procedures and Good Clinical Practices, study protocol, case report forms and informed consent designs. Oversaw MDR’s, complaint handling, database management and statistical consultants. Participated in FDA investigational site & Sponsor inspections, submission of a supplement to an approved PMA with a successful outcome. Involved in various cross-functional projects including establishing new health insurance codes for reimbursement, marketing, sales and attending trade shows throughout the U.S. and Europe. Show less