Clinical Compliance & Process Lead, Senior Specialist

Lundbeck A/S, H; København; In loco; DKK 786.000 - 1.081.000; Tempo pieno

Descrizione del lavoro

Lundbeck is seeking a Clinical Compliance & Process Manager, Senior Specialist, to translate GCP, quality and risk requirements into practical ways of working that ensure high-quality clinical trial delivery.

You will operate at the intersection of clinical operations, risk management, and process development, advising trial teams, shaping SOPs and guiding sponsor oversight across outsourced and hybrid models. A hands-on, pragmatic approach is essential.

Competenze

• Solid experience in clinical trials from a sponsor and/or CRO environment, ideally including global trial management or a comparable operational role.
• Strong knowledge of ICH-GCP and experience with 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.

Mansioni

• Translate regulatory and procedural requirements into pragmatic solutions to support trial delivery.
• Strengthen sponsor oversight and risk-based quality management through risk discussions and documented activities.
• Shape and maintain Clinical Operations processes, SOPs, and guidance across outsourcing models.

Conoscenze

Clinical trials

GCP knowledge

Risk management

Sponsor oversight

CRO collaboration

Descrizione del lavoro

Lundbeck is seeking a Clinical Compliance & Process Manager, Senior Specialist, to translate GCP, quality and risk requirements into practical ways of working that ensure high-quality clinical trial delivery.

You will operate at the intersection of clinical operations, risk management, and process development, advising trial teams, shaping SOPs and guiding sponsor oversight across outsourced and hybrid models. A hands-on, pragmatic approach is essential.