Clinical Studies Manager

One Great Company !!!!! Clinical Studies Manager – Job Description The Company We provide systems and services for digital pathology, which is a digital environment for the management and interpretation of pathology information, originating with a digital slide. We serves pathologists and other professionals practicing in clinical, research and education settings. Digital pathology information management software improve the efficiency and quality of pathology services. We are seeking a Clinical Studies Manager to join its rapidly growing team in a fast-paced environment. Summary This position will lead the study efforts, manage all initiated studies, and oversee customer-initiated studies (clinical / non-clinical) at study sites which include national laboratories, academic medical centers and hospital laboratories. This position will act as liaison between the company and its study sites and study investigators. Primary Responsibilities Acts as liaison between the company and the sites and study investigators Designs studies and prepares study protocols Manage studies and monitors study progress and study sites Assists in development of study strategies Prepares study manuals and study tools Prepare study reports and provides periodic updates to management Additional Responsibilities Assist with negotiation of study agreements Oversees customer-initiated studies involving our products Travels to study sites as required Assists in preparation of FDA submissions Participates in sales and marketing activities as requested Required Qualifications 3 to 5 years experience managing FDA studies (medical device experience preferred) Working knowledge of laws and regulations (e.g., FDA, privacy, etc.) pertaining to clinical and non-clinical studies and IRBs Healthcare background (e.g., registered nurse, licensed practical nurse, etc.) Willingness to travel 10 to 30% of the time Preferred Qualifications Working knowledge of pathology or oncology Anatomic pathology laboratory experience a plus BS in related field Location and type: Full-time employment in (Northern San Diego) or elsewhere in the US Compensation and benefits: We pays our great people salaries commensurate with market value, and provides full benefits including medical insurance and a 401(k) plan. All employees participate in our stock option plan. Contact We are committed to attracting and retaining the most highly qualified candidates available. As an employee you will be consistently challenged to deliver your best. Because we provide our customers the best technologies and service in the industry, you will constantly develop new skills, learn new products, and be involved in activities that are highly valued in the marketplace. Contact us by sending your resume to casam100@aol.com Please include the position title in the subject line of your email. Objectives for First Nine Months: 1. Immediately take and demonstrate ownership of the clinical studies area and create a written report for your supervisor, which will include status update on current studies in progress within 60 days of start date. 2. Within 90 days of start date, prepare and present to supervisor proposed study design and study protocols regarding both feasibility and performance studies in support of digital slide reading application (diagnosis) for selected tissue types. This work will include identifying and enrolling study sites and study investigators. 3. Within 3 to 6 months, offer meaningful and productive assistance to supervisor in the areas of study strategy and direction of Clinical Studies in general; commence execution of agreed study strategy. 4. Assist with managing to conclusion studies in progress. Negotiate and conclude execution of study agreements for new studies. 5. Prepare and provide to supervisor a written monthly progress report summarizing all study and study-related activities and progress to date. 6. Become the chief interface between the company and study sites and investigators, including interfacing between internal marketing and sales departments and Key Opinion Leaders / Principal Investigators at Academic Medical Centers and other study sites regarding studies and study related matters. 7. Within 6 to 9 months, familiarize yourself with existing Management Tools and institute a robust study management tool for the purpose of tracking and reporting all of above.

  Compensation: Full salary and benifits package Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests.