Clinical Science Manager

hace 5 días

Madrid, Madrid, España Qiagen A tiempo completo
Job Summary

We are seeking a highly skilled Clinical Science Manager to join our team at Qiagen. As a Clinical Science Manager, you will play a critical role in gathering clinical evidence and presenting it to regulatory bodies in support of our In-Vitro Diagnostic (IVD) product range.

Key Responsibilities
  1. Clinical Evidence Gathering: Manage the delivery of clinical / performance evaluation plans, scientific validity reports, clinical / performance evaluation reports to support Global Clinical Affairs activities around medical device (MD) / IVD and Companion Diagnostics development, registration and marketing.
  2. Project Management: Manage external contractors and vendors, ensuring projects are delivered within budget and to timeline.
  3. Collaboration and Communication: Collaborate with internal project stakeholders (including but not limited Medical Affairs, Product Development, Quality, Regulatory) and external partners.
  4. Regulatory Compliance: Review / contribute to non-clinical QIagen documents and represent Clinical Affairs on multi-functional teams to ensure requirements are met for IVDR / FDA and ROW compliance.
  5. Process Improvement: Update, review and contribute to SOPs and drive continuous improvement within the Clinical Affairs team including training other staff and representing QIagen in industry working groups.
Requirements

We are looking for a candidate with a Master's degree (preferably PhD) in Life Sciences with a minimum 3 years' employment experience with in vitro diagnostic devices and / or a clinical setting. Experience within oncology and / or companion diagnostics is preferred.

What We Offer

At Qiagen, we value our employees and offer a dynamic and collaborative work environment. We are committed to creating a diverse and inclusive workplace and are proud to be an equal opportunity employer. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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