Clinical Data Manager

Company: MDC Associates
Location: Beverly
Posted on: March 21, 2023

Job Description:

• Develop, build, and maintain databases of clinical trial data and establish tracking tools to track study-related data per the protocols.
• Contribute to the development of study-specific data management processes including Statistical Analysis Plans, Data Management Plans, Case Report Forms, and other study documentation.
• Collaborate with project managers, project leads, and consultants to develop appropriate statistical analysis methods.
• Act as expert for data collection and acquisition, advising teams and stakeholders on best -practices and proposing innovative solutions.
• Manage the database implementation, including lock and close-out processes and procedures.
• Create submission-ready study data packages per regulatory agency's requirements in -collaboration with the Regulatory and Clinical Affairs team.
• Collaborate with the Clinical Affairs team to ensure all study data is complete, timely, and -accurate.
• Comfortable with data entry and database creation in Microsoft Access.
• General understanding of statistical analysis techniques, including standard deviations, -confidence intervals, sample size determination, etc. -
  • Ability to interpret study protocols and internal procedures to meet database and output -requirements. Computer skills including proficiency in the use of Office 365, Microsoft Word, -Excel, Access, Outlook, and PowerPoint. Coding skills are a plus.
  • Strong written and verbal communication skills including good command of English language. - Excellent organizational, problem-solving, and time management skills. - Attention to detail and accuracy in work. - Ability to manage competing priorities without compromising quality
  • Support routine internal data audits of projects.
  • Support the harmonization of data management processes between MDC project teams.
  • Create training materials for EDC users and provide project-specific training as required.
  • Identify and implement new hardware and software tools as needs arise.Powered by JazzHR

Keywords: MDC Associates, Boston , Clinical Data Manager, Executive , Beverly, Massachusetts