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
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