Clinical Database Developer

Kforce has a client that is seeking a Clinical Database Developer in Fairfax, VA. Key Tasks:

• Be responsible as a performer or an oversight Clinical Database Developer across multiple projects for the following, but are not limited to data management activities and deliverables in various phases of the clinical trial lifecycle (e.g., pre-study start, study start up, study conduct, and study closure)
• Participation in the review of SOPs, work instructions, policies, manuals/user guides, and documents related to data collection and management activities and testing and validation documentation of data management systems
• Participation in the protocol review (from the initial drafts to finalization and subsequent amendments)
• Creation and maintenance of mock electronic case report forms (eCRFs) for electronic data collection method or CRFs for paper-based data collection method designed conforming to the required study data standards and the protocol-specific requirements and objectives
• Participation in the creation and maintenance of Data Management Plans (DMPs) describing the processes and procedures governing the data management activities for producing data management deliverables
• Participation in the creation and maintenance of Data Validation Plans (DVPs) outlining quality control checks on CRF data that will be performed manually or programmatically within or externally from the protocol-specific data management databases
• Design, development, testing, validation, and maintenance of protocol-specific data management databases meeting and conforming to the approved mock eCRFs (or similar documentation listing the agreed data point collection) or approved database modification requests (post-go live), required study data standards, the protocol-specific requirements and objectives, applicable regulations and guidelines, and the respective systems capabilities and requirements
• Bachelor's degree in Computer Science, or a related discipline, or the equivalent combination of education, professional training, or work experience
• 5 years of related clinical database development experience and must have experience providing clinical research data management oversight support