Mgr Centralized Study Support
Career Category
Clinical DevelopmentJob Description
Manager, Centralized Study Support (CSS)
Role Name: ManagerCentralized 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, fullerand longer. We discover, develop, manufactureand deliver innovative medicines to help millions of patients. Amgen helped establishthe biotechnology industry more than 40 years ago and remainson the cutting-edgeof innovation, using technology and human genetic data to push beyond what’sknown today.
ABOUT THE ROLE
Role Description:
The Manager, CSS is accountable for hiring, managing, mentoringand 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, accountabilityand continuous growth.
Organize and lead continuous development training sessions where appropriate
Resource Allocation & Program Engagement
Collaborate with Resource Points of Contact to ensure optimalassignment 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
Identifygaps 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 operatewithin SOPs, regulatory guidelinesand 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 clinicalexecution experience OR
Associate’s degree and 8 years of clinicalexecution experience OR High school diploma / GED and 10 years of clinicalexecution experience
PreferredQualifications and Experience:
5yearswork experience in life sciences industry, particularly focusing on clinical trial work, including 3years 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 optimizingresource allocation to ensure cost efficiencies
Strong collaboration and communication skills to engage with cross-functional teams, senior managementand 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 identifyoperational risks based on protocol design and implement innovative mitigation strategies. Identifyand manage study issues, communicatingand/or escalatingappropriately.
Able to identifyand implement opportunities for continuous improvement into the team’s working practices
Clear understanding of risk-based site monitoring ensuring regulatory compliance and timelyimplementation 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 participatein 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.
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