Clinical Data Management Specialist

Title: Clinical Data Management Specialist

Our client, an established and growing medical device company, is seeking a Clinical Data Management Specialist to support the planning, implementation, and execution of clinical data management activities across multiple clinical studies. This individual will play a key role in ensuring high-quality clinical data by leading EDC database development, overseeing data review activities, and partnering with cross-functional teams throughout the clinical trial lifecycle.

• Lead clinical data management activities from study startup through database lock and final data delivery.
• Develop and maintain study-specific data management documentation, including data management plans, edit check specifications, and other essential study documentation.
• Ensure clinical data is accurate, complete, and compliant with applicable regulations and internal quality standards.
• Participate in study planning meetings and provide data management expertise throughout study execution.

• Design, build, and maintain clinical study databases within an Electronic Data Capture (EDC) system.
• Configure electronic case report forms (eCRFs), edit checks, data validation rules, and user permissions.
• Coordinate and execute User Acceptance Testing (UAT) to validate database functionality prior to study launch.
• Support database updates, maintenance, lock activities, and archival throughout the course of clinical studies.

• Perform ongoing data review to identify missing, inconsistent, or erroneous clinical data.
• Generate, track, and resolve data queries in collaboration with investigative sites, CROs, and internal study teams.
• Perform data reconciliation activities and identify trends impacting overall data quality.
• Develop and communicate study data metrics and status updates to project stakeholders.

• Partner with Clinical Operations, Biostatistics, Clinical Science, and external vendors to support study objectives.
• Provide training and guidance on EDC systems and study-specific data collection processes.
• Contribute to process improvements that enhance data quality, efficiency, and operational consistency.

• Bachelor's degree in Life Sciences, Health Sciences, or a related field (or equivalent combination of education and experience).
• 2+ years of experience in Clinical Data Management supporting clinical trials.
• Hands‑on experience designing and programming studies within an Electronic Data Capture (EDC) system.
• Experience building electronic case report forms (eCRFs), edit checks, and database validation rules.
• Strong understanding of GCP, clinical research regulations, and clinical data management best practices.
• Experience performing data review, query management, and data cleaning activities.