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 Clinical Data Associate to join the Orthopedic Research department. The successful candidate will work alongside the team organizing and managing research data to contribute to advances in the medical community. Experience as a clinical data professional, knowledge of clinical regulatory regulations and data management is required. Excellent communication and analytical skills, and a bachelor’s degree in a related field are required for success in this position. Come join our growing and talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:? 

Assisting the clinical research team in running the day-to-day operational activities of data management for clinical studies. Assist in the development and maintenance of software utilized for data collection. 

Essential Duties and Responsibilities:  

• Participates in overall department strategy to provide clinical data needed for regulatory requirements, and marketing and reimbursement initiatives for new and existing products. 
• Support internal clinical data management initiatives.? 

• Supports clinical research team, clinical research sites in the daily use of data systems and ensures adherence to regulatory and company standards. 
• Build study specifics and the global database utilizing study protocol and configuration specifications. 
• Provides demos of the database to prospective clients.? ? 
• Performs User Acceptance Testing (UAT) 
• Author the creation of study-specific training instructions. 

• Assure data software agreements and training are executed before providing user access. 
• Provides technical expertise and training for end-users of data management systems. 
• Performs and documents edits checks and manual listing reviews according to study specifications. 
• Provides key stakeholders data analysis, custom reports, data extracts, study metrics and other deliverables as defined in the data management plan and ad hoc. 
• Data cleaning and delivery activities up to and including database lock.? 

• Author and manage standard operating procedures, work instructions and training documents.?? 
• Provides pertinent data collection updates for monthly department newsletter. 
• Establish and maintain relationships with key surgeons and administrators. 
• Coordinates vendor and client billing and account reconciliation. 
• Some travel may be required for studies and/or surgeon meetings (approximately 10%). 

Education and Experience:? 

• Bachelor's degree required.  Preferably in business, life science or computer science. 
• 1 year of clinical research data management experience required 
• 1 year of experience in study database build is preferred 

Knowledge and Skill Requirements/Specialized Courses and/or Training:? 

• Knowledge of ICH guidelines, FDA Regulations and GCP including international regulatory requirements for the conduct of clinical development programs, especially related to data handling and processing is desirable.?? 
• Prior trial responsibility of the entire data management lifecycle is desirable. 
• Experience in medical device trials is preferred. 
• Working knowledge of studies software is required. 
• Comprehension of medical terminology or can reference literature for understanding is required. 

• Proficient software skills: Word/ Excel/ PowerPoint/database is required. 

Machine, Tools, and/or Equipment Skills: 

PC, Clindex database, SOS, research tools, internet research tools. 

Education and Experience:? 

• Bachelor's degree required.  Preferably in business, life science or computer science. 
• 1 year of clinical research data management experience required 
• 1 year of experience in study database build is preferred 

Knowledge and Skill Requirements/Specialized Courses and/or Training:? 

• Knowledge of ICH guidelines, FDA Regulations and GCP including international regulatory requirements for the conduct of clinical development programs, especially related to data handling and processing is desirable.?? 
• Prior trial responsibility of the entire data management lifecycle is desirable. 
• Experience in medical device trials is preferred. 
• Working knowledge of studies software is required. 
• Comprehension of medical terminology or can reference literature for understanding is required. 

• Proficient software skills: Word/ Excel/ PowerPoint/database is required. 

Machine, Tools, and/or Equipment Skills: 

PC, Clindex database, SOS, research tools, internet research tools.