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.