BD (Becton, Dickinson and Company) Associate Post-Market Clinical Study Specialist in Covington, Georgia
Bard has joined BD, together advancing the world of health. BD Urology & Critical Care, formerly Bard Medical, is looking to fill the position of Associate Post-Market Clinical Study Specialist located in Covington, GA.
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.
This position includes the following duties and responsibilities. Other duties may be assigned.
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)
o 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. o Minimum 2 years relevant experience in medical device/drug clinical research. o Strong medical, technical or clinical background required. Strong command of medical and surgical terminology. o Effective written, verbal and presentation skills in the area of technical/clinical applications.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear. The employee will sometimes be required to move around in manufacturing facility or meet with medical professionals in a hospital environment. Specific vision abilities required by this job include close vision and color vision.
Employee is required to meet with other personnel in other areas of the building.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position is in an office environment.
No special work environment conditions other than minimal exposure to manufacturing environment (i.e. noise, minimal heat and some chemical fume exposure), laboratory, and hospital settings.
Career Level: entry level
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 8195 Industrial Blvd.
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.