Requisition ID: 58648 Title: Clinical Data Supervisor Division: Arthrex, Inc. (US01) Location: Naples, FL
**This position is based in Naples, FL. Relocation assistance provided**
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 Clinical Data Supervisor. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.
Main Objective:
Supervise clinical data professionals assigned to conduct data management activities for clinical studies. To 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. Participate in data management strategies for regulatory and marketing initiatives.
Essential Duties and Responsibilities:
Participates in overall department strategy to provide clinical data for regulatory requirements, marketing, and reimbursement initiatives for new and existing products.
Supervises Data Management Team
Manages resource assignments across projects.
Assess the competency of the Data Management Team to satisfy position responsibilities and evaluate their performance.
Provides expert review and advice for the creation of Data Management deliverables, including electronic Case Report Forms (eCRFs), database design and specification, User Acceptance Testing (UAT), study-specific eCRF instructions, Data Management Plan (DMP), data cleaning, database lock, reports, and extracts.
Enforces processes for effective data management in an electronic database (EDC), electronic trial master files (eTMF), electronic patient-reported outcomes (ePRO), and Clinical Trial Management System (CTMS)
Provide advice and solutions to issues to improve efficiency.
Monitor quality and efficiency across projects to identify trends and improvement opportunities.
Conducts data management meetings as appropriate and provides clinical team updates regarding data listings, issues, cleaning, and locking.
Assures databases and archives are protected from security breaches and losses.
Develop and maintain data management standard operating procedures, work instructions, and training documents.
Education and Experience:
Master's degree preferred. Preferably in business, life science, or computer science.
Bachelor's degree required. Preferably in business, life science, or computer science.
Seven years of clinical research data management experience preferred.
Two years of supervisory experience required.
Clinical or Data Management Certification is required or obtained in two years.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Through knowledge of guidelines and regulations 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 and eTMF is required.
Ability to supervise and mentor team.
Ability to lead multiple projects at the same time.
Individuals 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: Microsoft Office/ Word/ Excel/PowerPoint/database is required.
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.
