Our client, a leading manufacturer of medical devices is hiring a Clinical Data Supervisor.
Work Location: Naples, FL
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.
Machine, Tools, and/or Equipment Skills:
- PC, laptop, and printer.