Senior Clinical Research Operations Manager (m/f/d)

<p><span><span><span><span><span><span>You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova and Advanced Bionics, we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.</span></span></span></span></span></span></p> <p> </p> <p><span><span><span><span><span><span>We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best. </span></span></span></span></span></span><span><span><span><span><span><span>If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.</span></span></span></span></span></span></p> <p><span><span><span><span><span><span>Join Sonova. Create sense.</span></span></span></span></span></span></p> <p> </p> <p><span><span><span><span><span><span>Senior Clinical Research Operations Manager (m/f/d)</span></span></span></span></span></span></p> <p><span><span><span><span><span><span>Remote working possible (within Germany)</span></span></span></span></span></span></p> <p> </p> <p><span><span><span><span><span><span>We are looking for a Clinical Affairs team member responsible for the operation of </span></span></span><span>clinical studies, </span><span><span><span>which include the project management of clinical studies, handling of investigational devices, and communication with ethics boards, authorities and notified bodies. </span></span></span></span></span></span></p> <p><span><span><span><span><span><span>You will help to lead project planning, budgeting, resource tracking, and status reporting. Further, you will ensure that essential study documents are maintained, and the clinical study conduct is completed in manner compliant with business procedures and relevant regulations. </span></span></span></span></span></span></p> <p> </p> <p><span><span><span><b><span><span><span>        Our Offer for your Engagement:</span></span></span></b></span></span></span></p> <ul> <li><span><span><span><span><span><span>Exciting and challenging work environment</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Collaborative culture; atmosphere of mutual trust in a highly motivated, international team</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Permanent contract, Flexible working times, JobRad, attractive pay according to achievement, 30 days annual holiday</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>A company that values diversity and inclusion</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>You help to improve the quality of life of millions of people with hearing loss!</span></span></span></span></span></span></li> </ul> <p> </p> <p><span><span><span><b><span><span><span> Main tasks and responsibilities:</span></span></span></b></span></span></span></p> <ul> <li><span><span><span><span><span><span>Leading the operational planning, tracking, and closure of clinical studies for medical devices</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Leading collaboration with cross functional teams to secure support necessary for clinical studies</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Proactively engaging with clinical and business leadership to report on study status and, when necessary, presents scenarios for maintaining on-time and on-budget study progress</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Responsible for preparing and reviewing essential study documents while ensures that clinical studies are conducted in compliance with relevant regulatory requirements and Sonova relevant procedures</span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Ensuring on time submission to and communication with ethics committees and authorities </span></span></span></span></span></span></li> <li><span><span><span><span><span><span>Provides oversight for Trial Master File development, maintenance, and reconciliation through onsite and remote monitoring</span></span></span></span></span></span></li> </ul> <p> </p> <p><span><span><span><b><span><span><span>         Your profile:</span></span></span></b></span></span></span></p> <ul> <li><span><span><span><span><span><span>Bachelor’s degree in a me