Job Description Summary
The Associate Post-Market Clinical Study Specialist will manage clinical data collection efforts in the development and execution of strategies to obtain information and support concerning medical devices requiring clinical data for the purpose of facilitating worldwide registration. The specialist will assist in authoring post-market clinical follow up (PMCF) plans, executing PMCF activities, analyzing data collected, and summarizing in evaluation reports. The specialist will ensure compliance with federal and applicable regulatory agency requirements, and SOPs. The Specialist drives value by performing/coordinating activities, information, and tools to produce excellent results aligned with project goals and milestones.
The Specialist may work independently or as part of a larger team in the execution of assigned projects.
Essential Job Functions:
Coordinates, assists in, or leads the development and execution of study- or project-related deliverables, including but not limited to, project and operational plans, status reports, and other project-related documents.
Conducts Post Market Clinical Follow-Up projects / studies according to sponsor protocols, including but not limited to, start-up activities, site selection, initiation, interim monitoring and close-out.
Tracks project spending and provide financial updates as requested.
Collaborate with Quality, Clinical, Regulatory, Marketing and other cross-functional partners to provide input to the Post-Market Clinical Program.
Ensure compliance with Bard/BD standards, policies and procedures, Good Clinical Practice, and local, regional, and federal regulations.
Develops and maintain therapeutic and device operation knowledge literature required to support identified products and related clinical studies, stays informed about applicable clinical landscapes and trends; apply this knowledge to the development of well-written, clear and concise reports.
Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities.
Participate in work streams and or process improvement initiatives.
Able to appropriately apply different standards related to medical devices/ clinical research (SOPs, GCP, ISO, ICH, FDA, MedDev, EU MDR, etc.) as needed.
Basic understanding of statistics and statistical methods.
Able to coordinate and lead multiple projects simultaneously in a fast-paced work environment.
Demonstrates initiative, is decisive, guides and motivates others.
Able to identify problems and root causes and propose potential solutions and initiate action independently.
Strongly motivated, is able to achieve work goals, and executes through formal channels.
Demonstrable proficiency with the Microsoft suite of applications (Access, Excel, Internet Explorer, Outlook, PowerPoint, Project, SharePoint, Word)
Education and/or Experience:
A minimum of a B.S. degree in a health science or related field, preferably with a focus on clinical research, operations, technology, and/or project management is required. Graduate degree in Epidemiology/Public Health or Clinical Research is preferred.
Minimum 2 years relevant experience in medical device/drug clinical research.
Strong medical, technical or clinical background required. Strong command of medical and surgical terminology.
Effective written, verbal and presentation skills in the area of technical/clinical applications.
Primary Work Location
USA GA - Covington BMD
Researcher / analyst
Covington , United States