Senior Clinical Compliance Specialist
4 hours ago
Clinical Operations Overview
Lundbeck is a global biopharmaceutical company dedicated to improving the quality of life for people affected by brain disorders. Our innovative and dynamic team works together to shape the future of neurology and psychiatry.
Salary Range
The estimated annual salary for this role is between $85,000 - $120,000, depending on experience and qualifications.
About the Role
We are seeking a highly skilled Senior Clinical Compliance Specialist to join our Clinical Operations team in Copenhagen, Denmark. As a key member of our team, you will be responsible for ensuring our clinical trial processes and documentation meet regulatory standards and support the seamless execution of our clinical trials.
Your Responsibilities
- Develop and implement a robust compliance framework that fosters a culture of adherence and accountability.
- Lead the implementation of Veeva Vault eTMF and enhance Lundbeck's eTMF operational strategy, ensuring consistent compliance with relevant guidelines.
- Contribute to the development of a comprehensive risk management system and Standard Operational Procedures.
- Deliver impactful training for employees on compliance policies and procedures.
- Represent Clinical Operations in cross-functional initiatives, promoting a cohesive and effective approach to compliance throughout the organization.
Your Profile
To be successful in this role, you will have:
Comprehensive expertise in process development, risk, and issue management.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.About Us
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.
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