Clinical Data Manager, Sr. (remote)

Location: Remote ER Bonus: $2500.00 Salary Range: Salary Minimum: $79.001,00 Salary Maximum:  140,000.00

 

**Travel required to Naples headquarters quarterly for 1 week**

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: Act as the primary liaison for data management deliverables on assigned studies. Provide senior-level guidance and support to the Data Managers team across multiple large-scale studies. Supervise the preparation of data collection forms, database design, specification and testing, cleaning, locking, extracting, and reporting on study progress for internal and external stakeholders. Collaborate with clinical research, data managers, and other internal teams, focusing on continuous process enhancement, issue resolution, workload forecasting, and technical consultation. Participate in data management strategies for regulatory and marketing initiatives.

 

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 creation of data management plans and data review plans (DMP & DRP), as well as 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, ePRO 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 the 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 manual listing review activities according to the DMP and DRP.
• Manage ongoing query review with closures of system-generated queries according to the DMP and DRP.
• 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 Completion Guidelines.
• 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 including 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 (3 years of that time as a study lead role preferred).

 

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

• Clinical Data Management certification (i.e. CCDM) is preferred (required to be obtained within 1 year of hire if not already held).
• 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 understandi