Clinical Operations Compliance Specialist
1 month ago
Clinical Compliance and Process Management plays a crucial role in ensuring our clinical trial processes meet regulatory standards at Lundbeck. As Clinical Operations Compliance Specialist, you will be responsible for developing and implementing a robust compliance framework that fosters a culture of adherence and accountability.
Your new role will involve collaborating with the innovative and dynamic CCPM team to enhance Lundbeck's eTMF operational strategy using Veeva Vault eTMF. You will contribute to the development of a comprehensive risk management system and deliver impactful training for employees on compliance policies and procedures.
In addition, 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.
As part of Clinical Operations, you will be working with a diverse team of 36 employees conducting clinical studies in over 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.
Key responsibilities include process development, risk and issue management, and knowledge sharing. Proficiency in document management, preferably with experience in Veeva Vault eTMF, is essential. A strong understanding of ICH-GCP, relevant regulations, laws, and clinical study management is also required.
We offer a competitive salary of approximately $80,000 - $100,000 per annum, depending on qualifications and experience. Located in Copenhagen, Denmark, this exciting opportunity comes with a chance to work in a dynamic and innovative environment. If you are passionate about making a difference in patients' lives and committed to excellence, we want to hear from you.
Lundbeck offers a rewarding career with a mix of exciting tasks and development opportunities balanced with initiatives focused on your well-being. We are committed to building a diverse workforce that reflects the people we serve. Learn more about our company culture and values at www.lundbeck.com.
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