Dexian · 16 hours ago
Clinical Data Specialist
Dexian is a leading provider of staffing, IT, and workforce solutions. The Clinical Data Specialist is responsible for coordinating data management activities across multiple studies and contributing to data management process improvements within the clinical data management lifecycle.
Responsibilities
Assist with the creation and/or review study-specific Case Report Forms (CRFs) using device study knowledge and protocol specific information in collaboration with clinical team
As applicable, contribute to the development of Case Report Form Library of common forms that can be used consistently across studies
Support EDC database development(s)
Participate in the validation and User Acceptance Testing (UAT) of EDC databases
Develop and/or review study-specific data management and database documentation, which may include Data Management Plan (DMP), CRF Completion Guidelines (CCGs), Annotated CRFs, Edit/Logic Check Specifications, and UAT Plans
Collaborate with clinical team members to generate data review guidelines and perform data review and query generation/closure
Prepare data for scheduled snapshots/database locks and perform archival activities upon study completion
Attend study-specific team meetings and produce requested metrics, which may include query information or data trends
Train Investigators and Coordinators on the EDC system, and CRF completion guidelines as needed
Manage EDC user access for sponsor and site personnel
Qualification
Required
Bachelor's degree is strongly preferred
Requires 2+ years of clinical data and EDC experience
Strong computer skills with a proficiency with MS Windows based applications
Working knowledge of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials including applicable ISO regulations for any trials conducted globally
Preferred
Able to prioritize workload, assign realistic completion dates, and complete assignments on schedule
Excellent written and oral communications skills required
Comfortable with multiple Electronic Data Capture (EDC) Systems
Strong organizational skills and attention to detail
Ability to work independently and manage multiple tasks in a fast-paced, changing environment
Medical Devices preferred
Company
Dexian
Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.
H1B Sponsorship
Dexian has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (65)
Funding
Current Stage
Late StageRecent News
2025-11-19
Company data provided by crunchbase