Clinical Data Specialist

Job Overview

Essential Functions

• Serve as Data Operations Coordinator (DOC) for several global clinical trials or serve in a leadership role to a specific data management task.
• With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead
• Provide specific eCOA or Clinical DM task or technology expertise. Manage delivery of projects through full data management process life-cycle. With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify out-of-scope. Provide comprehensive data management expertise (including all operations tasks ). Perform comprehensive quality control procedures. Independently bring project solutions to the eCOA DM team.
• communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with eCOA DM and project teams. Interact with eCOA DM team members to negotiate timelines and responsibilities."
  

Qualifications

• Working knowledge of SAS software a plus, but not required.
  

• 3 years of related experience including clinical trials experience in a function similar to data management. Equivalent combination of education, training and experience.
• Thorough knowledge of the data management process. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III). Comprehensive understanding of clinical drug development process. Excellent organizational, communication, and data management skills (detail oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients. Thorough knowledge of the data management process. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III). Comprehensive understanding of clinical drug development process. Excellent organizational, communication, and data management skills (detail oriented). Ability to establish and maintain effective working relationships with coworkers, managers and clients.