Our client, a global medical devices company is hiring a Manager of Clinical Data.
Work Location: Naples, FL (hybrid)
- 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.