Mgr Centralized Study Support

<h2><b>Career Category</b></h2>Clinical Development<h2></h2><h2><b>Job Description</b></h2><div><div><p><b><span>M</span><span>anager, Centralized Study Support (CSS)</span></b><span> </span></p></div><div><p><b><span>Role Name: </span></b><span><span>Manager</span><span> </span><span>Centralized Study Support (CSS)</span></span><span> </span></p></div><div><p><b><span>Role GCF: </span></b><span><span>5</span></span><span> </span></p></div><div><p><u><span>ABOUT AMGEN</span></u><span> </span></p></div><div><p><span><span>Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, </span><span>fuller</span><span> and longer. We discover, develop, </span><span>manufacture</span><span> and deliver innovative medicines to help millions of patients. Amgen helped </span><span>establish</span><span> the biotechnology industry more than 40 years ago and </span><span>remains</span><span> on the </span><span>cutting-edge</span><span> of innovation, using technology and human genetic data to push beyond </span><span>what’s</span><span> known today.</span></span><span> </span></p></div><div><p><span><span> </span></span><span> </span></p></div><div><p><u><span>ABOUT THE ROLE</span></u><span> </span></p></div><div><p><u><span>Role Description:</span></u><span> </span></p></div><div><p><span><span>The Manager, CSS is accountable for hiring, managing, </span><span>mentoring</span><span> and growing a team of Study Delivery Associates and Sr Associates</span><span>.</span></span><span><span>  </span></span><span><span>The role is accountable for continually developing the CSS roles within their team, ensuring they are positioned to deliver high-quality operational support to clinical programs and managing performance issues effectively and compassionately</span><span>.</span></span><span><span>  </span></span><span> </span></p></div><div><p><u><span>Roles &amp; Responsibilities:</span></u><span><span> </span></span><span> </span></p></div><div><p><b><span>Team Management</span></b><span> </span></p></div><div><ul><li><p><span><span>Recruit, onboard and train (in partnership with R&amp;D Training) new team members to meet current and future program needs</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Provide regular mentoring, coaching and competency development support for all direct reports</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Proactively manage team risks, including attrition and performance challenges</span><span>.  </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Foster a positive team culture, focused on collaboration, open communication, </span><span>accountability</span><span> and continuous growth. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Organize and lead continuous development training sessions where appropriate </span></span><span> </span></p></li></ul></div><div><p><b><span>Resource Allocation &amp; Program Engagement </span></b><span> </span></p></div><div><ul><li><p><span><span>Collaborate with Resource Points of Contact to ensure </span><span>optimal</span><span> assignment of team members based on skills, experience, and workload.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Monitor resourcing needs and proactively address capacity or skill gaps.</span></span><span> </span></p></li></ul></div></div><div><div><ul><li><p><span><span>Ensure team members are appropriately prepared for their roles within each assigned program.</span></span><span> </span></p></li></ul></div><div><p><b><span>Capability Development &amp; Continuous Improvement</span></b><span> </span></p></div><div><ul><li><p><span><span>Identify</span><span> gaps in skills, processes, or tools and implement targeted development or training initiatives.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Support knowledge sharing across the team to build collective </span><span>expertise</span><span>.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Encourage innovative solutions and best practice adoption to enhance operational effectiveness.</span></span><span> </span></p></li></ul></div><div><p><b><span>Stakeholder Collaboration</span></b><span> </span></p></div><div><ul><li><p><span><span>Serve as the main point of contact for performance escalations related to CSS team members</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Build strong relationships with internal stakeholders to align team development &amp; allocation with the broader needs of the business </span></span><span> </span></p></li></ul></div><div><p><b><span>Quality &amp; Compliance </span></b><span> </span></p></div><div><ul><li><p><span><span>Support the development of team oversight metrics and regularly report progress towards them / swiftly address risks &amp; issues. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ensure all team members </span><span>operate</span><span> within SOPs, regulatory </span><span>guidelines</span><span> and quality standards.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Support audit &amp; inspection readiness.</span></span><span> </span></p></li></ul></div><div><p><b><span>Resource Management Support</span></b><span> </span></p></div><div><ul><li><p><span><span>Provide support to the SDRM Resource Management team as needed</span><span>.  </span><span>Support may include management of hiring, allocations and forecasting analysis for in scope roles. </span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><u><span>Basic Qualifications and Experience:</span></u><span> </span></p></div><div><ul><li><p><span><span>Doctorate degree OR</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Master’s degree and 2 years of clinical execution experience OR</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Bachelor’s degree and 4 years </span><span>of  clinical</span><span> execution experience OR</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Associate’s degree and 8 years </span><span>of  clinical</span><span> execution experience OR High school diploma / GED and 10 years </span><span>of  clinical</span><span> execution experience</span></span><span> </span></p></li></ul></div></div><div><div><p><u><span>Preferred</span><span> Qualifications and Experience:</span></u><span> </span></p></div><div><ul><li><p><span><span>5</span><span> </span><span>years</span><span> work experience in life sciences industry, particularly focusing on clinical trial work, including </span><span>3</span><span> years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Experience managing multiple teams / direct reports across multiple clinical functions</span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><u><span>Competencies</span><span>:</span></u><span> </span></p></div><div><ul><li><p><span><span>Ability to manage, mentor, and develop professionals and support staff across functions &amp; geographies, while fostering collaboration across internal and external teams for trial success</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Experience with overseeing study budgets and financial operations, reviewing/approving site expenditures, and </span><span>optimizing</span><span> resource allocation to ensure cost efficiencies</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Strong collaboration and communication skills to engage with cross-functional teams, senior </span><span>management</span><span> and external stakeholders, internally and externally</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Navigates diverse regulatory, cultural, and operational environments</span><span>.  </span><span>Builds strong relationships across geographies and time zones.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ability to </span><span>identify</span><span> operational risks based on protocol design and implement innovative mitigation strategies. </span><span>Identify</span><span> and manage study issues, </span><span>communicating</span><span> and/or </span><span>escalating</span><span> appropriately.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Able to </span><span>identify</span><span> and implement opportunities for continuous improvement into the team’s working practices</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Clear understanding of risk-based site monitoring ensuring regulatory compliance and </span><span>timely</span><span> implementation of Corrective and Preventive Actions (CAPA) to mitigate risks, resolve operational challenges and ensure inspection readiness</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Experience with developing and training teams related to clinical trial materials (e.eg., CRAs, site staff, and cross-functional teams) to ensure alignment with study protocols, regulatory requirements, and best practices</span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><u><span>EQUAL OPPORTUNITY STATEMENT</span></u><span> </span></p></div><div><p><span><span>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.</span></span><span> </span></p></div><div><p><span><span>We will ensure that individuals with disabilities are provided with reasonable accommodation to </span><span>participate</span><span> 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 </span><span>an accommodation</span><span>.</span></span><span> </span></p></div><div><p><span> </span></p></div></div><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.