Clinical Compliance & Process Manager, Senior Specialist

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

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

You bring strong clinical trial experience and are comfortable applying GCP and operational knowledge to real-world situations. We are looking for someone who can connect quality requirements with the practical realities of trial delivery.

• 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.

You are pragmatic and solution-oriented, with sound risk-based judgement. You enjoy collaborating across functions, are comfortable working through ambiguity and challenge constructively when needed. Most importantly, you are curious and enjoy helping others find workable solutions rather than simply pointing to the rule.

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 www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

Annual base salary range: 786 000 - 1 081 300 DKK 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 www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).