Manager, Data Management Division

**This position in based in Naples, FL. Relocation assistance available**

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 Manager of Clinical Data. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Main Objective: 

Responsible for leading and growing the Clinical Data Management Team and 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:

• Provides leadership in developing best practices for measuring and optimizing clinical data management initiatives.
• Subject matter expert for clinical data management systems.
• Supervise Clinical Data Management Team by establishing responsibilities, empowering their Individual Development Plan, and providing ongoing mentoring.
• Creates and enforces effective database build and data management processes in EDC, CTMS, and eTMF systems.
• Oversee the study-specific database build using study protocol and configuration specifications.
• Enforces compliance with project and data management plans for data handling and sharing with the clinical research team.
• Lead User Acceptance Testing (UAT)
• Supports clinical research team, clinical data team sites in the daily use of data systems and ensures adherence to legal and company standards.
• Supervises adequacy and documentation of data management training internal and external stakeholders.
• Enforce the edit checks and manual listing review activities according to study specifications.
• Supervise ongoing query review with closures of system-generated queries at least monthly and before monitoring visits.
• Supervise 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.
• Lead the troubleshooting activities for data-related problems and provide maintenance or authorizes modification.
• Lead QC functions activities – using edit checks, data listings, and other available tools/reports, manage quality control of data to ensure accurate, complete data is provided according to study timelines and contract described deliverables. 
• Lead data cleaning and delivery activities – manage clinical data cleaning and delivery activities and include database lock. 
• Develop and maintain data management standard operating procedures, work instructions, and training documents
• Leads distribution of interim metrics reports to key stakeholders.

Education and Experience: 

• Bachelor's degree required, preferably in business, life science or computer science.
• Master's degree preferred.
• Ten years of clinical research data management experience required.

Knowledge and Skill Requirements/Specialized Courses and Training: 

• Thorough knowledge of ICH guidelines, FDA Regulations, and GCP, including international regulatory requirements for conducting clinical development programs, especially related to data handling and processing, is required. 
• Prior trial responsibility of the entire data management life cycle is desirable.
• Experience in medical device trials is preferred.
• Working knowledge of EDC studies are required.
• Good knowledge of the Clindex system is preferred.
• Ability to communicate effectively with peers, cross-functional partners, and internal and external stakeholders.
• Ability to work effectively with little supervision and strong attention to detail in a team environment.
•  Ability to work effectively on multiple projects at the same time.
• Individual must be highly motivated and self-directed. •
• Excellent written and verbal communication skills.
• Comprehension of medical terminology or can reference literature for understanding is required.
• Proficient software skills: Word/ Excel/ PowerPoint/database is required.

Machine, Tools, and Equipment Skills:

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

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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
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)
• Eligible for discretionary Long Term Incentive program

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.