eClinical Solutions Offices

Processes and quality-checks external and local laboratory data throughout clinical trials. Reviews protocols, eCRF designs, vendor data transfers, normal ranges, reconciliation logs, exception listings, and clinical database alignment. Supports study start-up, data documentation, issue resolution, reporting, metrics, and vendor agreements while ensuring ICH/GCP, SOP, and data integrity standards. Collaborates with clinical data management, project teams, clients, laboratories, and vendors.

Perform centralized medical coding and serious adverse event reconciliation for clinical trials. The role maintains coding guidelines and SAE plans, codes using MedDRA and WHODrug, reviews coding accuracy, resolves discrepancies with clinical and safety teams, documents decisions, supports dictionary versioning, and tests coding tools and deployments while ensuring compliance with clinical research regulations and quality standards.

Leads clinical trial data management across the full study lifecycle, including database design, validation, data cleaning, reconciliation, query resolution, reporting, database freeze and lock. Serves as the primary sponsor liaison, oversees timelines and deliverables, delegates work, mentors team members, supports testing and training, maintains study documentation, and drives process improvement. Uses centralized data management platforms and clinical analytics to ensure high-quality, compliant data deliverables.