Jobs at Ergomed PLC

Lead and manage clinical trials end-to-end: plan and oversee resources, train staff, ensure GCP and SOP compliance, manage TMF and vendors, support regulatory/IRB submissions, control budgets and profitability, prepare for audits, and contribute to study documentation and company SOPs and training.

Manage clinical data activities for trials: design CRFs and databases, program/test edit checks, perform coding (MedDRA/WHO‑Drug), export CDISC SDTM datasets, generate queries, coordinate data entry and DB developers, support database lock and sponsor communication.

Lead and manage clinical trials end-to-end: plan, staff, train, monitor quality and compliance (GCP/SOP), manage vendors, budgets, regulatory/EC/IRB submissions, TMF maintenance, reporting to sponsor and senior management, support audits, and contribute to SOPs and company training.

Lead regulatory management for international clinical trials: develop Regulatory Management Plans and study-specific FMEAs, prepare and submit CTAs/amendments/notifications/reports, liaise with regulatory authorities and sponsors, review CSRs for regulatory compliance, provide regulatory training, and line-manage small regulatory teams.