JOB OVERVIEW:

Pharmaron is seeking a Clinical Data Coordinator to join our growing team in Somerset, NJ. In this role, you will ensure the integrity, reliability, and accuracy of clinical trial data across multiple studies. You’ll work closely with internal and external teams to manage data, develop key documents, and ensure compliance with regulatory requirements and industry standards.

• Ensure clinical data quality, consistency, and compliance with GCP, regulatory requirements, SOPs, and data standards.
• Manage data transfer specifications and ensure external data meets required standards.
• Develop and review data management documents such as data management plans, eCRF completion guidelines, and coding/reconciliation plans.
• Conduct ongoing data review, cleaning, and reconciliation throughout the trial lifecycle.
• Lead small to medium-sized clinical trials (e.g., BE, Phase I/II), including resource allocation and workload assessment.
• Design and test Case Report Forms (CRFs), edit checks, and database functionalities.
• Generate and manage queries, coding of medical terms, and quality control of coding outputs.
• Provide regular reports, listings, and risk assessments to the Lead Data Manager (LDM) and stakeholders.
• Support audits, regulatory inspections, and client/vendor communications.
• Mentor junior team members and contribute to process improvements.