Sr. Clinical Data Manager (remote)

Requisition ID:          59149 Title: Sr. Clinical Data Manager (remote) Division: Arthrex, Inc. (US01) Location: Remote Salary Range: Salary Minimum: $75,000.00 Salary Maximum $140,000.00

 

 

 

 

**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)