Jobs 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.

Builds and maintains electronic data capture systems for complex clinical research projects using Medidata RAVE and Zelta. Responsibilities include configuring study structures, workflows, edit checks, randomization, ePRO, IMP management, SDV, user permissions, documentation, testing, training materials, and post-live changes under change control. The role applies CDASH and SDTM standards and collaborates with data management teams in pharmaceutical clinical research.

Conduct and lead pharmacovigilance audits across Europe, including planning, execution, reporting, follow-up, and CAPA development. Apply GVP and global regulatory expertise while delivering quality assurance projects for pharmaceutical and biotechnology clients. The role is freelance, available full-time or at least 0.6 FTE, supports remote audits, and requires up to 40% travel.

Leads business development and sales strategy for CRO services across the UK and Nordic markets. Responsibilities include account expansion, market development, proposal leadership, sponsor presentations, bid defenses, contract and budget negotiations, client relationship management, competitor monitoring, and attendance at industry events. The role requires substantial CRO sales experience, pharmaceutical and biotechnology networks, clinical-trial regulatory awareness, strong negotiation and presentation skills, leadership, and business travel.

Serve as primary client contact for pharmacovigilance projects, define scope and objectives, plan activities and milestones, manage client expectations, prepare reporting and monthly reports to support invoicing, and ensure delivered PV services meet quality standards.

Lead and line-manage an ICSR processing team for assigned projects, oversee workflow and KPIs, support ICSR processing and 2nd QC, propose process improvements, manage deviations, act as team SME and liaise with clients to ensure quality and efficiency.

Serve as primary client contact for pharmacovigilance projects: define scope, plan activities and milestones, manage client expectations, prepare reports and invoicing, and ensure PV deliverables meet quality and regulatory standards.