Mgr Centralized Study Support

Manager, Centralized Study Support (CSS)

Role Name: Manager Centralized Study Support (CSS)

Role GCF: 5

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

The Manager, CSS is accountable for hiring, managing, mentoring and growing a team of Study Delivery Associates and Sr Associates.  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. 

Roles & Responsibilities:

Team Management

• Recruit, onboard and train (in partnership with R&D Training) new team members to meet current and future program needs
• Provide regular mentoring, coaching and competency development support for all direct reports
• Proactively manage team risks, including attrition and performance challenges. 
• Foster a positive team culture, focused on collaboration, open communication, accountability and continuous growth.
• Organize and lead continuous development training sessions where appropriate

Resource Allocation & Program Engagement

• Collaborate with Resource Points of Contact to ensure optimal assignment of team members based on skills, experience, and workload.
• Monitor resourcing needs and proactively address capacity or skill gaps.
• Ensure team members are appropriately prepared for their roles within each assigned program.

Capability Development & Continuous Improvement

• Identify gaps in skills, processes, or tools and implement targeted development or training initiatives.
• Support knowledge sharing across the team to build collective expertise.
• Encourage innovative solutions and best practice adoption to enhance operational effectiveness.

Stakeholder Collaboration

• Serve as the main point of contact for performance escalations related to CSS team members
• Build strong relationships with internal stakeholders to align team development & allocation with the broader needs of the business

Quality & Compliance

• Support the development of team oversight metrics and regularly report progress towards them / swiftly address risks & issues.
• Ensure all team members operate within SOPs, regulatory guidelines and quality standards.
• Support audit & inspection readiness.

Resource Management Support

• Provide support to the SDRM Resource Management team as needed.  Support may include management of hiring, allocations and forecasting analysis for in scope roles.

Basic Qualifications and Experience:

• Doctorate degree OR
• Master’s degree and 2 years of clinical execution experience OR
• Bachelor’s degree and 4 years of  clinical execution experience OR
• Associate’s degree and 8 years of  clinical execution experience OR High school diploma / GED and 10 years of  clinical execution experience

Preferred Qualifications and Experience:

• 5 years work experience in life sciences industry, particularly focusing on clinical trial work, including 3 years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
• Experience managing multiple teams / direct reports across multiple clinical functions

Competencies:

• Ability to manage, mentor, and develop professionals and support staff across functions & geographies, while fostering collaboration across internal and external teams for trial success
• Experience with overseeing study budgets and financial operations, reviewing/approving site expenditures, and optimizing resource allocation to ensure cost efficiencies
• Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally
• Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles
• Navigates diverse regulatory, cultural, and operational environments.  Builds strong relationships across geographies and time zones.
• Ability to identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues, communicating and/or escalating appropriately.
• Able to identify and implement opportunities for continuous improvement into the team’s working practices
• Clear understanding of risk-based site monitoring ensuring regulatory compliance and timely implementation of Corrective and Preventive Actions (CAPA) to mitigate risks, resolve operational challenges and ensure inspection readiness
• 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

EQUAL OPPORTUNITY STATEMENT

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.

We will ensure that individuals with disabilities are provided with 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.