Clinical Data Specialist

Position Overview

The Clinical Data Specialist plays a key role in ensuring accurate, consistent, and compliant clinical trial data across CTMS and Electronic Data Capture (EDC) systems. This role is responsible for source data verification, data entry, query resolution, and quality control processes to support high-quality data management across clinical studies.

Key Responsibilities

Source Data Verification & Data Entry

• Perform quality control review on source documentation to ensure accuracy and completeness.
• Transfer source data into EDC systems such as Medidata RAVE, Veeva Vault EDC, Oracle Clinical One, Inform.
• Ensure all entries are accurate, complete, and consistent with source documentation.
• Validate source documents to ensure adherence to ALCOA-C principles.

Query Management & Issue Resolution

• Identify discrepancies and resolve data queries in a timely and efficient manner.
• Track and escalate recurring data issues, patterns, or potential protocol deviations.
• Recommend corrective and preventive actions to enhance data quality.

Compliance & Quality Assurance

• Ensure data processes follow GCP, ALCOA-C, HIPAA, clinical protocols, and regulatory requirements.
• Participate in ongoing validation, QC checks, and data reconciliation activities.
• Support internal audits, sponsor audits, and regulatory inspections.

Clinical Documentation & eSource Support

• Review protocols, lab manuals, CRF completion guidelines, and study-related documentation.
• Assist in preparation and refinement of study documents such as eCRFs, source templates, and site tools.

Cross-Functional Collaboration

• Work alongside Clinical Operations, CRIO Specialists, Finance, and Data Management teams to ensure seamless data capture.
• Communicate effectively with site teams, investigators, sponsors, and CROs.
• Provide feedback to leadership on process improvement opportunities.

Qualifications & Experience

• Bachelors degree in Life Sciences, Pharmacy, Nursing, Medicine, or related field (required).
• Masters degree preferred.
• Minimum 3 years of experience as a CRC or in clinical data management.
• Hands-on experience with CTMS and EDC systems.
• Strong understanding of clinical protocols, CRF guidelines, and data management workflows.
• Knowledge of ICH-GCP, HIPAA, ALCOA-C.
• Proficiency in Microsoft Office.
• Strong communication and organizational skills.
• Willingness to work aligned with U.S. hours.