Clinical Compliance and Process Manager, Senior Specialist

Cari; København; Hybrid; DKK 786,000 - 1,081,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Clinical trials experience

ICH-GCP knowledge

Sponsor oversight

Process development

Inspection readiness

Risk management

Job description

Clinical Compliance & Process Manager, Clinical Operations

Your clinical trial experience could be just what we are looking for. As our next Clinical Compliance & Process Manager, you will help turn GCP, quality and risk requirements into practical ways of working that support high-quality clinical trial delivery.

Your new role

As a Clinical Compliance & Process Manager (CCPM), you will work at the intersection of clinical trial operations, GCP compliance, risk management and process development. You will be a trusted advisor to clinical trial teams, helping colleagues navigate complex operational and GCP questions and translate regulatory and procedural requirements into pragmatic solutions. You will strengthen sponsor oversight and risk-based quality management by facilitating risk discussions and helping teams define proportionate, meaningful and well-documented oversight activities. You will also shape and maintain Clinical Operations processes, SOPs, work instructions and guidance, and work with CROs and internal stakeholders to clarify responsibilities and establish effective ways of working across different outsourcing models. The role gives you the opportunity to influence how we work across Clinical Operations, including supporting inspection readiness, audits and inspections, privacy and informed consent matters, and acting as an unblinded sponsor representative when required.

Your future team

You will join our Clinical Compliance & Process Management (CCPM) team within Clinical Operations. We are a small, experienced team that works closely with colleagues responsible for clinical trials and with stakeholders across the wider organisation. We value collaboration, knowledge sharing, openness and constructive challenge, and we aim to make our processes compliant and robust while also practical, proportionate and simple enough to work in the reality of clinical trial delivery.

The position is based in Copenhagen, Denmark.

What you bring to the team

• 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.

Applications must be received by23.10.2026.

Our promise to you

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities, balanced with initiatives focused on your well-being.

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at lundbeck/global/about-us/our-commitment/diversity-and-inclusion.

Annual base salary range: 786 000 - 1 081 300DKK gross

At Lundbeck, we are committed to fair and transparent pay. Please note that the final base salary within the stated range will be based on relevant qualifications, skills, competencies, and level of proficiency as well as internal pay equity.

Learn more about us at lundbeck, LinkedIn or Instagram (h_lundbeck).