Teams at Ergomed

Leads oncology operational strategy for potential clinical trial awards, developing competitive proposals and supporting bid defenses. Collaborates with business development, project management, clinical operations, data management, statistics, regulatory, and safety teams. Builds client relationships, supports repeat business, participates in client meetings and conferences, and contributes marketing content such as webinars and white papers.

Leads study start-up and regulatory activities to achieve site initiation readiness across assigned countries and projects. Prepares and reviews regulatory submissions, essential documents, translations, site agreements, and patient materials for ICH-GCP and country-specific compliance. Develops regulatory strategies and start-up plans, provides subject matter expertise, manages milestones and risks, and coordinates with internal teams, clients, sites, and external stakeholders.

Leads the ICSR Management Unit, overseeing resources, productivity, budgets, staff utilization, quality activities, CAPAs, procedures, recruitment, and business development. Manages Associate Directors and senior staff, reallocates resources, establishes productivity targets, supports proposals and contracts, coordinates with Quality and Operations, and drives process improvements. Requires extensive pharmacovigilance case-processing experience across post-marketing and clinical settings, plus senior leadership experience.