Clinical Compliance & Process Lead — GCP, Risk & Quality

Lundbeck; København; On-site; DKK 786,000 - 1,081,000; Full time

Job summary

Lundbeck is seeking a Clinical Compliance & Process Manager to translate GCP and quality requirements into practical ways of working for high-quality trial delivery. You will advise trial teams and strengthen sponsor oversight across operations, with a focus on risk-based quality management and process development.

Based in Copenhagen, Denmark, you will work with the CCPM team within Clinical Operations, collaborating across outsourcing models and supporting inspections, privacy, and consent

Qualifications

• Solid experience in clinical trials from sponsor and/or CRO.
• Strong knowledge of ICH-GCP.
• Experience with sponsor oversight and risk-based quality management.
• Experience developing and maintaining clinical processes, SOPs and work instructions.
• Experience with outsourced or hybrid CRO operating models.
• Experience supporting inspection readiness and audits/inspections.

Responsibilities

• Translate GCP, quality and risk requirements into practical ways of working for trial delivery.
• Advise clinical trial teams on regulatory and operational questions.
• Strengthen sponsor oversight and facilitate risk discussions.
• Shape and maintain Clinical Operations processes and SOPs.
• Collaborate with CROs and internal stakeholders across outsourcing models.
• Support inspection readiness, audits and inspections, privacy and consent matters.

Skills

Clinical trials

ICH-GCP

Risk management

Sponsor oversight

Quality management

Process documentation

CRO collaboration

Inspection readiness

Privacy & consent

Job description

Lundbeck is seeking a Clinical Compliance & Process Manager to translate GCP and quality requirements into practical ways of working for high-quality trial delivery. You will advise trial teams and strengthen sponsor oversight across operations, with a focus on risk-based quality management and process development.

Based in Copenhagen, Denmark, you will work with the CCPM team within Clinical Operations, collaborating across outsourcing models and supporting inspections, privacy, and consent