Senior Manager, Clinical Affairs – Clinical Submissions

Overview At the heart of QIAGEN's business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. Our most valuable asset are our employees - more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us. There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started. If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic, international and diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be. Join us. At QIAGEN, you make a difference every day. Position Description This is a Global role, we are looking for a candidate to be located within the UK, France, Poland or Spain. The Senior Manager will lead a team within the Clinical Affairs department at QIAGEN. They will use their advanced knowledge of clinical operations (and in particular ethical and National Competent Authority submissions across EU and associated countries) in order to bring new diagnostics to the market for improvement of patient care. The role is pivotal in ensuring that every sample matters and all necessary approvals and notifications are in place for use in QIAGEN performance studies. The role holder will have extensive experience in all regulatory considerations prior to proceeding with clinical studies. In addition, they will have solid knowledge of clinical trial management pertinent to FDA and IVDR. Key responsibilities: Establish and maintain efficient and compliant submissions management for all QIAGEN analytical and clinical performance studies as well as implementation of effective management tools. Establish and oversee all clinical submissions for clinical studies. Have responsibility for developing and maintaining global processes relating to clinical submissions (including process maps, SOP's, procedural documents, training materials) in the Clinical Affairs department. Develop and maintain all country specific submission requirements for national competent authorities and ethical committees. Coordinate, supervise and train internal and external teams as required. Empower individual and team growth. Have overall responsibility to ensure that all personnel at QIAGEN are supported and trained to the appropriate level for the role they play in all elements of sample management and logistics. Have responsibility for training and oversight of registration of QIAGEN sponsored clinical studies on CT.GOV. Position Requirements Bachelor's degree in Life Sciences, Biomedical Engineering, Nursing or similar; or equivalent experience. Advanced degree preferred. Minimum 6 years' employment experience within Clinical Operations (with special reference to biospecimen management and oversight). Experience of team leadership, including team development and lead culture promoting high performance standards. Willingness and availability to travel nationally and internationally: up to 10%. What we offer At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN. QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

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