Clinical Data Supervisor

2 months ago

Naples, United States TSR Consulting Services, Inc. Full time

Our client, a leading medical devices company is hiring a Clinical Data Supervisor on a full time basis.



Work Location: Naples, FL (hybrid) - relocation assistance available.

Job #: 79477


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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