Coordinates data management activities in support of clinical and/or non-clinical research studies including document management, query management, database setup and testing, and quality control of the data and project deliverables.
- Track and maintain audit-ready clinical study documentation within the electronic and/or hard copy Trial Master Files for multiple projects
- Participate in database setup including programming specification document creation and review, data entry screen and validation check writing and testing, Case Report Form Completion Guidelines development, etc.
- Perform data entry and query management including data listing review, query creation and resolution
- Assist Clinical Data Manager in allocating and prioritizing workloads for multiple projects, as needed
- Serve as an interim resource for study issues pertaining to data management in the absence of the Clinical Data Manager
- Assume Clinical Data Manager responsibilities for small studies
- Mentor and train Clinical Data Associate in query management and other CDA activities
- Maintain quality control of the data, project deliverables and closeouts
- Generate, send and track receipt of Training Forms for new database users; complete User Access Request Forms
- Participate and/or lead internal and external team meetings, as necessary
- Assume any tasks outlined in Clinical Data Associate job description, as needed
- Adhere to all aspects of the SDC’s quality system
- Comply with SDC’s data integrity & business ethics requirements
- Perform other duties as assigned
- Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
- Working knowledge of clinical trials and data management’s role in the clinical trials process
- Proficiency with Microsoft Word and Excel software and other MS office products (MS Powerpoint, MS Project, etc.)
- Ability to work well in a team environment
- Excellent organizational skills and attention to detail
- Ability to successfully work on multiple projects and prioritize daily tasks and responsibilities
- Effective communications skills both written and verbal
- Possess strong problem-solving skills, be solution-oriented
- Familiarity of regulatory guidelines (FDA/CFR, ICH/GCP)
- Additional skills include the following: familiarity with electronic data capture systems and/or clinical research coordinator role
Education or Equivalent Experience
- Bachelor’s degree, preferably in applied or life science, with 1-3 years of experience in data management of clinical trials or equivalent education and work experience.