Clinical Data Supervisor

Our client, a leading manufacturer of medical devices is hiring a Clinical Data Supervisor.

Work Location: Naples, FL - relocation package offered

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.

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