Data Specialist

CEDAR HEALTH RESEARCH LLC•Dallas, TX

2d•Remote

About The Position

The Data Specialist ensures the accuracy, integrity, and timeliness of clinical trial data from study startup through closeout. The role supports data collection, review, and cleaning in compliance with GCP, ICH guidelines, FDA regulations, sponsor requirements, IRB approvals, and internal SOPs. The Data Specialist works closely with Principal Investigators, CRCs, Regulatory staff, monitors, sponsors, and CROs to support high-quality research execution. The position is fully remote, with no onsite presence or travel required. It requires independent work, a dedicated private workspace that protects data confidentiality, prolonged computer use, and reliable secure internet. The role requires availability during core business hours (CST), with occasional early mornings, evenings, or weekends to meet sponsor or database-lock deadlines. Occasional virtual participation in monitoring visits, audits, or inspections may be required.

Requirements

2–5 years of clinical research data-management experience, including site-level experience with EDC entry.
Strong working knowledge of GCP, ICH, FDA regulations, HIPAA, and the clinical trial lifecycle.
Hands-on experience with major EDC/eSource platforms such as Medidata, Oracle, Veeva, or RealTime, and Microsoft Office.
High attention to detail, strong organizational and communication skills, and ability to manage multiple studies simultaneously.
Ability to work independently and maintain a dedicated private workspace that protects data confidentiality.
Reliable, secure internet access.
Availability during core business hours (CST), with occasional early mornings, evenings, or weekends to meet sponsor or database-lock deadlines.

Nice To Haves

Bachelor’s degree in Life Sciences, Health Sciences, Data Management, or a related field.
Experience in complex therapeutic areas or device trials.
Familiarity with CTMS, eRegulatory/eSource platforms, and remote or centralized monitoring.
Experience supporting database locks or interim analyses.
Clinical research certification (e.g., CCDM, CCRC, CCRP) or equivalent training.

Responsibilities

Perform accurate EDC data entry and ongoing data review across multiple studies, ensuring consistency with source documentation.
Generate, track, and resolve data queries with CRCs and investigators within sponsor timelines.
Support remote monitoring, SDV readiness, database-lock activities, and interim and final analyses.
Maintain study data in EDC, eSource, CTMS, and related systems, including user access and role-based permissions.
Support study startup activities such as CRF review, data-entry guidelines, and system training.
Identify opportunities to improve data workflows and efficiency.
Ensure data handling complies with GCP/ICH, FDA regulations, HIPAA, IRB approvals, and sponsor requirements.
Maintain accurate documentation of data corrections, audit trails, and data-management activities.
Support audits, inspections, and CAPA development for data-related findings.
Serve as a primary point of contact for data-related questions from sponsors, CROs, and monitors.
Participate in sponsor meetings, data-review meetings, and internal study-team discussions.
Coordinate with Regulatory and Quality teams to ensure aligned documentation.