Clinical Research Data Manager Location:

Kansas City, MO (Hybrid or Remote Considered)

Job Type:

Full-Time or Part-Time (Flexible Based on Experience) About Us Spectrum Clinical Research is a growing clinical research organization dedicated to advancing healthcare through high-quality clinical trials. We are seeking a detail-oriented and organized Clinical Research Data Manager to support multiple clinical research studies while ensuring data quality, regulatory compliance, and timely database management. Position Summary The Clinical Research Data Manager is responsible for overseeing clinical trial data throughout the study lifecycle. This role works closely with Clinical Research Coordinators, Investigators, Sponsors, and CROs to ensure accurate, complete, and timely data entry, query resolution, and compliance with

GCP, FDA

regulations, and study protocols. Responsibilities Enter, review, and maintain clinical trial data in sponsor electronic data capture (EDC) systems. Review source documentation for accuracy and completeness. Resolve sponsor and CRO data queries promptly. Track outstanding queries and ensure timely completion. Perform routine quality control and data validation checks. Assist with protocol deviations, adverse event documentation, and regulatory documentation as needed. Collaborate with Clinical Research Coordinators and Investigators to maintain data integrity. Maintain study trackers and data metrics. Prepare for sponsor monitoring visits and regulatory inspections. Ensure compliance with

ICH-GCP, FDA

regulations, and sponsor requirements. Qualifications Required Experience in clinical research. Knowledge of GCP and FDA regulations. Experience with Electronic Data Capture (EDC) systems. Excellent organizational skills and attention to detail. Strong written and verbal communication skills. Ability to manage multiple studies and priorities simultaneously. Preferred Experience as a Clinical Research Coordinator or Clinical Data Manager. Familiarity with systems such as Medidata Rave, RealTime CTMS/eSource, Calyx, or similar platforms. CCRC, CCRP, or equivalent certification is a plus. Skills Data management Clinical documentation Query management Regulatory compliance Microsoft Office and Excel Problem solving Time management Team collaboration Benefits Flexible scheduling Competitive compensation based on experience Professional development opportunities Opportunity to work on a variety of clinical trials Supportive and collaborative team environment How to Apply Please submit your resume along with a brief cover letter highlighting your clinical research and data management experience. Qualified candidates will be contacted for an interview.

Work Location:

Hybrid remote in Kansas City, MO 64118