Strategic Clinical Compliance & Process Lead

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

Job summary

Lundbeck seeks a Clinical Compliance & Process Manager to turn GCP, quality and risk requirements into practical ways of working that support high-quality clinical trial delivery. You will advise trial teams, enable sponsor oversight and shape processes, SOPs and guidance across outsourced and hybrid models, including privacy and consent considerations and inspection readiness.

Based in Copenhagen, Denmark, you will collaborate with Clinical Operations and CROs to ensure robust, compliant

Qualifications

• Solid experience in clinical trials from a sponsor and/or CRO environment.
• Strong knowledge of ICH-GCP and sponsor oversight, risk-based quality management and facilitation of clinical trial risk assessments.
• Experience developing and maintaining clinical processes, SOPs, work instructions or guidance, and working with CROs in outsourced or hybrid operating models.
• Experience supporting inspection readiness, audits or inspections and/or applying privacy, informed consent or unblinded sponsor requirements in clinical trials.

Responsibilities

• Turn GCP, quality and risk requirements into practical ways of working that support high-quality clinical trial delivery.
• Act as a trusted advisor to clinical trial teams, translating regulatory and procedural requirements into pragmatic solutions.
• Strengthen sponsor oversight and risk-based quality management by facilitating risk discussions and defining proportionate oversight activities.
• Shape and maintain Clinical Operations processes, SOPs, work instructions and guidance, and collaborate with CROs and internal stakeholders across outsourcing models.
• Clarify responsibilities and establish effective ways of working across different outsourcing models.
• Support inspection readiness, audits and inspections, privacy and informed consent matters, and act as an unblinded sponsor representative when required.

Skills

Clinical trials

ICH-GCP

Sponsor oversight

Risk-based quality management

Risk assessments

Process SOPs

CRO collaboration

Inspection readiness

Privacy & informed consent

Job description

Lundbeck seeks a Clinical Compliance & Process Manager to turn GCP, quality and risk requirements into practical ways of working that support high-quality clinical trial delivery. You will advise trial teams, enable sponsor oversight and shape processes, SOPs and guidance across outsourced and hybrid models, including privacy and consent considerations and inspection readiness.

Based in Copenhagen, Denmark, you will collaborate with Clinical Operations and CROs to ensure robust, compliant