Sr. Clinical Data Manager (Remote)

**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, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Clinical Data Manager.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Main Objective: 

Oversee the day-to-day operational activities of data management for clinical studies. Lead the development and maintenance of software utilized for data collection.

Essential Duties and Responsibilities:

• Lead data management efforts for internal and outsourced studies; may manage staff responsible for performing those activities.
• Lead data management activities, including data management plans (DMP), and training materials.
• Lead development and review of SOPs, work instructions, and associated documents for CDM, including recommendations, revisions, and updates to SOPs.  
• Creates and enforces processes for effective database build and data management in EDC, CTMS, and eTMF systems.
• Support the development of study-specific database builds using study protocol and configuration specifications.
• Is compliant with project and data management plans for data handling and sharing with the clinical research team.
• Oversees/Performs User Acceptance Testing (UAT)
• Supports clinical research team and sites in the daily use of data systems and ensures adherence to legal and company standards.
• Facilitate stakeholder training of data management systems.
• Lead the edit checks and manual listing review activities according to study specifications.
• Manage ongoing query review with closures of system-generated queries at least monthly and before monitoring visits.
• Lead the distribution of data reports, extracts, and other deliverables as defined in the data management plan.
• Conducts data management meetings as appropriate and provides clinical team updates regarding data listings, issues, cleaning, and locking.
• Lead and coordinate the creation of study-specific eCRF instructions.
• Assures databases and archives are protected from security breaches and losses.
• Manage troubleshooting activities for data-related problems
• Manage Clinical Data cleaning and delivery activities and include database lock. 

Education and Experience: 

• Bachelor's degree required. Preferably in Business, Life Science, or Computer Science.
• Master's degree preferred. Preferably in Business, Life Science, or Computer Science.
• A least 6 years of Clinical Data management experience is required

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

• Demonstrate knowledge of ICH/GCP guidelines as they relate to data management is required
• Demonstrate knowledge of ISO standards preferred
• Demonstrate knowledge of FDA Regulations related to data handling and processing, which is required
• A thorough understanding of CDISC CDASH and SDTM standards is preferred
• Prior trial responsibility of the entire data management lifecycle is required
• Experience working with medical device trials is preferred
• Knowledge of EDC and Clinical Data Management Systems required
• Comprehension of medical terminology or reference literature for understanding is required
• Proficiency in Microsoft Office Applications, specifically in MS Excel and project management, is required
• Experience in vendor oversight is preferred
• Experience in leading or mentoring Clinical Data teams is preferred

Machine, Tools, and/or Equipment Skills:

Microsoft Office, Electronic Data Capture system

Arthrex 2023 Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.