Director, Clinical Administration & Compliance

Pharmacosmos; Holbæk; Sur place; DKK 1 400 000 - 2 100 000; Plein temps

Résumé du poste

Pharmacosmos invites a hands-on, senior leader to establish and head a new Clinical Administration & Compliance function. You will combine people leadership with direct involvement in clinical trial administration, processes and operational GCP compliance.

As Director, you will lead TMF quality, sponsor oversight and inspection readiness, shaping risk-based, pragmatic workflows and robust documentation practices across R&D.

Qualifications

• Experience leading clinical operations
• Strong knowledge of ICH-GCP and regulatory expectations
• Hands-on with trial processes, SOPs and essential documentation

Responsabilités

• Lead the new Clinical Administration & Compliance function
• Translate regulatory requirements into practical workflows
• Ensure inspection readiness and sponsor oversight across R&D trials
• Drive continuous improvement in processes and documentation practices

Connaissances

Leadership

ICH-GCP knowledge

TMF & documentation

Regulatory compliance

Description du poste

Pharmacosmos invites a hands-on, senior leader to establish and head a new Clinical Administration & Compliance function. You will combine people leadership with direct involvement in clinical trial administration, processes and operational GCP compliance.

As Director, you will lead TMF quality, sponsor oversight and inspection readiness, shaping risk-based, pragmatic workflows and robust documentation practices across R&D.