Study Start-up Manager at Amgen

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<h2>Career Category</h2>Clinical<h2></h2><h2>Job Description</h2><div><div>HOW MIGHT YOU DEFY IMAGINATION? </div><div> </div><div>If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. </div><div> </div><div>STUDY START-UP MANAGER </div><div> </div><div>LIVE </div><div>What you will do </div><div> </div><div>In this vital role you will drive the planning and execution of clinical study start-up activities, ensuring trials are launched efficiently, compliantly, and to the highest quality standards. </div><div> </div><div>The responsibilities of the role will include: </div><div><ul><li>Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met. </li></ul></div><div><ul><li>Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track. </li></ul></div><div><ul><li>Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration. </li></ul></div><div><ul><li>Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start. </li></ul></div><div><ul><li>Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed. </li></ul></div></div><div><div><ul><li>Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution. </li></ul></div><div><ul><li>Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities. </li></ul></div><div><ul><li>Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub. </li></ul></div><div> </div><div>WIN </div><div>What we expect of you </div><div> </div><div>We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills: </div><div><ul><li>Degree educated </li></ul></div><div><ul><li>Clinical trial execution experience and previous experience leading people/teams and working in global teams across multiple geographies as well as project management experience </li></ul></div><div><ul><li>Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management </li></ul></div><div><ul><li>PMP Certification </li></ul></div><div> </div><div>THRIVE </div><div>What you can expect of us </div><div> </div><div>As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. </div></div><div><div><ul><li>Vast opportunities to learn and move up and across our global organization </li></ul></div><div><ul><li>Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act </li></ul></div><div><ul><li>Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits </li></ul></div><div> </div><div>LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. </div><div> </div><div>APPLY NOW </div><div>for a career that defies imagination </div><div>In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. </div><div> </div><div>careers.amgen.com </div><div> </div><div>Equal Opportunity Statement </div><div> </div><div>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. </div><div> </div><div>We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. </div><div> </div></div>.

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Study Start-up Manager

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Amgen

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