Senior Clinical Compliance and Operational Excellence Specialist
2 weeks ago
At Lundbeck, we are committed to creating innovative solutions that transform lives. As a Senior Clinical Compliance and Operational Excellence Specialist, you will play a critical role in ensuring our clinical trial processes and documentation meet regulatory standards.
Key Responsibilities:
- Develop and implement robust compliance frameworks that foster 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, standard operating procedures, and deliver impactful training for employees on compliance policies and procedures.
- Leverage technology tools to streamline compliance monitoring processes and represent Clinical Operations in cross-functional initiatives.
About the Role:
Clinical Operations is responsible for planning, managing, and coordinating international clinical phase I-IV studies. Our team consists of 36 employees conducting clinical studies in more than 50 countries worldwide. We foster an environment where every team member feels valued and empowered to contribute to our mission.
Clinical Compliance and Process Management 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.
Requirements:
- 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.
We Offer:
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.
Our estimated salary for this role is approximately €60,000 - €80,000 per year, depending on experience and qualifications.
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