Clinical Compliance & Process Architect

Cari; København; Híbrido; DKK 786.000 - 1.081.000; Jornada completa

Descripción de la vacante

Lundbeck seeks a Clinical Compliance & Process Manager to translate GCP, quality and risk requirements into pragmatic processes for high-quality trial delivery. You will advise clinical teams, foster risk-based quality management, and shape SOPs across CROs and internal stakeholders.

The role is based in Copenhagen and supports inspection readiness, audits and privacy matters. You will join a small CCPM team within Clinical Operations, collaborating with trial teams and broader stakeholders to

Formación

• Solid experience in clinical trials from sponsor and/or CRO environments.
• Strong knowledge of ICH-GCP and sponsor oversight.
• Experience developing and maintaining clinical processes, SOPs or guidance.
• Experience supporting inspection readiness, audits or inspections.

Responsabilidades

• Interpret regulatory requirements and convert them into practical ways of working for clinical trial delivery.
• Strengthen sponsor oversight and risk-based quality management through risk discussions.
• Shape and maintain Clinical Operations processes, SOPs and guidance across outsourcing models.

Conocimientos

Clinical trials experience

ICH-GCP knowledge

Sponsor oversight

Process development

Inspection readiness

Risk management

Descripción del empleo

Lundbeck seeks a Clinical Compliance & Process Manager to translate GCP, quality and risk requirements into pragmatic processes for high-quality trial delivery. You will advise clinical teams, foster risk-based quality management, and shape SOPs across CROs and internal stakeholders.

The role is based in Copenhagen and supports inspection readiness, audits and privacy matters. You will join a small CCPM team within Clinical Operations, collaborating with trial teams and broader stakeholders to