What are the responsibilities and job description for the Data Specialist position at CEDAR HEALTH RESEARCH LLC?
Job Summary:
The Data Specialist ensures the accuracy, integrity, and timeliness of clinical trial data from study startup through closeout. This 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.
Key Responsibilities:
Data Management & Quality Control
- 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/final analyses.
Electronic Systems & Tools
- 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.
Regulatory Compliance & Documentation
- 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.
Cross‑Functional Collaboration
- 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.
Qualifications:
Required
- 2–5 years of clinical research data management experience (site level experience including EDC entry).
- Strong working knowledge of GCP, ICH, FDA regulations, HIPAA, and the clinical trial lifecycle.
- Hands-on experience with major EDC/eSource platforms (e.g., Medidata, Oracle, Veeva, RealTime) and Microsoft Office.
- High attention to detail, strong organizational and communication skills, and the ability to manage multiple studies simultaneously.
Preferred
- 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/centralized monitoring.
- Experience supporting database locks or interim analyses.
- Clinical research certification (e.g., CCDM, CCRC, CCRP) or equivalent training is a plus.
Work Environment
- Fully remote; no onsite presence or travel required.
- Requires the ability to work independently and a dedicated, private workspace that protects data confidentiality.
- Prolonged computer use; reliable, secure internet required.
- Availability during core business hours (CST), with occasionally early mornings, evenings, or weekends to meet sponsor or database lock deadlines.
- Occasional virtual participation in monitoring visits, audits, or inspections.
Cedar Health Research is an equal opportunity employer. We welcome applicants of all backgrounds and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic.
Qualifications:Qualifications:
Required
- 2–5 years of clinical research data management experience (site level experience including EDC entry).
- Strong working knowledge of GCP, ICH, FDA regulations, HIPAA, and the clinical trial lifecycle.
- Hands-on experience with major EDC/eSource platforms (e.g., Medidata, Oracle, Veeva, RealTime) and Microsoft Office.
- High attention to detail, strong organizational and communication skills, and the ability to manage multiple studies simultaneously.
Preferred
- 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/centralized monitoring.
- Experience supporting database locks or interim analyses.
- Clinical research certification (e.g., CCDM, CCRC, CCRP) or equivalent training is a plus.