Clinical Compliance and Process Manager, Clinical Operations
H. Lundbeck A/S
Are you excited about taking a real difference in patients’ lives? Join us at Lundbeck as a Clinical Compliance & Process Manager Specialist. In this role, you will be critical in ensuring our clinical trial processes and documentation meet regulatory standards and support the seamless execution of our clinical trials. If you committed to excellence and compliance, we have the right job for you.
Your new role
As the Clinical Compliance and Process Manager (CCPM) at Lundbeck, you will be an integral part of our innovative and dynamic CCPM team. Your role will be crucial in shaping and implementing a robust compliance framework that fosters a culture of adherence and accountability.
Together with your colleagues, you will lead the implementation of Veeva Vault eTMF and enhance Lundbeck's eTMF operational strategy, ensuring consistent compliance with relevant guidelines. You will also contribute to the development of a comprehensive risk management system, Standard operational procedures and deliver impactful training for employees on compliance policies and procedures.
Additionally, you will leverage technology tools to streamline compliance monitoring processes and represent Clinical Operations in cross-functional initiatives, promoting a cohesive and effective approach to compliance throughout the organization.
Your future team
Clinical Operations is responsible for planning, managing, and coordinating international clinical phase I-IV studies, as well as conducting non-interventional studies. We are a team of 36 employees conducting clinical studies in more than 50 countries worldwide. Our culture is built on mutual respect, continuous learning, and a shared commitment to excellence. We foster an environment where every team member feels valued and empowered to contribute to our mission. Our goal is to create the ideal conditions for our team and our work, ultimately improving conditions for patients with unmet needs.
Clinical Compliance and Process Management (CCPM) is an enthusiastic section within Clinical Operations, consisting of a core team of 5 people working closely together with a high emphasis on collaboration, knowledge sharing, trust, and openness.
The position is based in Copenhagen, Denmark.
What you bring to the team
- Comprehensive expertise in process development, risk and issue management, and knowledge sharing.
- Proficiency in document management, with a preference for experience in Veeva Vault eTMF.
- Extensive knowledge of ICH-GCP, relevant regulations, laws, and clinical study management.
- Fluency in written and spoken English.
- Excellent teamwork skills.
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 that are 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
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Apply now
Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!
Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.
If you have questions, please contact Hanne Kusk Jacobsen, Director Clinical Operations on [email protected]. Applications must be received by December 12, 2024. We will review applications continuously, so please don't hesitate to send your CV.
Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).
#EveryBrainInTheGame
This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.
About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
About Lundbeck
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
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