Title: Senior Clinical Study Manager (Remote)
Company: Arthrex, Inc.
Location: Naples, FL
**This position is based in Naples, FL. Open to remote for the right candidate. If remote, travel to HQ for one week every quarter is required**
Arthrex is a global medical device company and leader in research, new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. The Orthopedic Research department based in Naples; includes a team of clinical, biomaterials and biomechanical professionals. Arthrex is actively searching for a Sr. Clinical Study Manager to join the Orthopedic Research department. The successful candidate will work alongside the team organizing and overseeing research studies to contribute to advances in the medical community. Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and a bachelor’s degree in a related field are required for success in this position. Clinical Research Professional certification is also strongly encouraged. Come join our growing talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
To develop, manages and facilitate activities related to the conduct of Arthrex sponsored clinical research studies.
Essential Duties and Responsibilities:
- Initiate clinical research for Arthrex sponsored studies
- Planning, executing, management, and oversight of clinical studies
- Leads the development and implementation of clinical protocols, informed consent forms, and study-related materials for clinical studies
- Manages site initiation activities (e.g., study start-up documentation preparation)
- Responsible for IRB communication including document preparation and submission of Arthrex study initiatives.
- Assist in implementing modifications to optimize protocol results or edit/amend study documentation if necessary
- Maintain appropriate monitoring and maintenance of Sites in approved clinical studies to ensure the overall successful conduct of assigned clinical studies
- Utilize Arthrex EDC for specific clinical research initiatives to conduct training of Site and/or staff
Monitoring Site data collection
- Set-up and maintain accurate progress and Site study status tracking logs to provide reports and updates of assigned clinical research projects
- Oversee follow-up and lead query resolution with sites via ongoing interactions
- Participation in investigator meetings, Site initiation, monitoring and close-out visits when applicable
- Complete central, remote, and on-site monitoring reports and follow-up letters
- Identify and mitigate quality risk and/or issues associated with assigned studies/activities
- Facilitate appropriate documentation to maintain compliance with the Finance and Compliance departments
- Prepare clinical study budgets
- Responsible for the timely completion of deliverables inclusive of analysis of large data sets/spreadsheets using excel or other applications for interim study status reporting to meet Arthrex and research goals
- Facilitate efficient utilization of available clinical data, addressing needs of internal and external stakeholders (e.g., publications)
- Works closely with leadership, Project Manager and Internal CRAs to manage assigned studies
- Execute clinical studies according to ICH/GCP guidelines, ISO guidelines, and internal SOPs
Education and Experience:
- Bachelor’s degree required. Master’s degree preferred.
- 5 plus years of relevant clinical research experience required.
- Minimum 2-year Sponsor/CRO requirement. Preferably, in a medical device industry environment.
- Clinical research monitoring experience preferred
- Familiarity with orthopedics and medical terminology is advantageous
- Strong research and technical writing skills and ability to review protocols and agreements for accuracy
- Ability to organize and manipulate large data sets
- Proficiency in Microsoft Office programs
- Clinical Research Certification required, or must be willing to obtain within 1 year of employment
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- An understanding of cross-functional clinical study processes is required.
- Ability to work in a team, good communication, documentation, and a strong understanding of data collection and analytical processes are required.
- The ability to identify a research hypothesis and proposed outcomes measures to address the hypothesis is a plus.
- The ability to read a surgical technique and have a basic understanding of the instruments necessary to perform the procedure is beneficial.
- Able to communicate effectively with physicians, key opinion leaders, and other healthcare personnel.
- Must have an understanding of institutional, state, and federal regulations relating to clinical studies and Good Clinical Practice (GCP)
- Experience managing research contracts and protocol development is required.
Machine, Tools, and/or Equipment Skills:
Computer experience in Microsoft Office is required
To apply for this position or to learn more, please click "Apply Online" below.
SOCRA Exp: 11/9/2023