Sr Mgr Centralized Study Support
Career Category
Clinical DevelopmentJob Description
Role Name: Sr Manager Centralized Study Support (CSS)
Role GCF: 6
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 Sr Manager, CSSis responsible forstrategic and operational leadership of multiple Managers within Centralized Study Support (CSS). This role ensures delivery of high-quality centralized operational support across clinical programs and alignment of resources with organizational priorities.
Roles & Responsibilities:
Team Management
Provide leadership, direction and mentorship to multiple Managers, Centralized Study Support.
Set strategic goals for the team in collaboration with Sr Mgrcolleagues and in alignment with corporate objectives
Ensure consistency in management practices, performance standardsand staff development approaches across all managers.
Monitor functional performance against KPIs, addressing challenges and capitalizing on opportunities for improvement.
Manager Development & Support
Coach and mentor managers to enhance their leadership, performance management& teambuilding capabilities.
Support managers in addressing complex performance or resourcing challenges.
Promote a culture of accountability, transparency, qualityand continuous learning across all levels.
Resource Planning & Program Engagement
Oversee resource allocation across Managers’ teams ensuring optimalalignment with program requirements.
Anticipate resourcing risks and pro-activelydevelop & execute effective mitigation plans.
Anticipate resourcing needs and partner with Talent Acquisition for timelyhiring and succession planning.
Stakeholder Collaboration & Communication
Build strong trust-based relationships with key stakeholders and act as the senior operational contact for escalations involving centralized study support teams,
Communicate succinct, effective functional updates, priorities, risksand successes to Director, SDRM
Quality & Compliance
Ensure all team members operatewithin SOPs, regulatory guidelinesand quality standards.
Capability Building & Continuous Improvement
Identifyorganizational skill gaps and develop a cohesive capability building strategy in partnership with Sr Mgr, CSS colleagues.
Lead initiatives to enhance processes, tools and systems that improve the quality, efficiencyand consistency of CSS (pro-activelyleveragingAI and other automation opportunities where appropriate).
Resource Management Support
Provide support to the SDRM team as needed. Support may include management of hiring, allocations and forecasting analysis for in scope roles.
Basic Qualifications and Experience:
Doctorate degree and 2 years of clinicalexecution experience OR
Master’s degree and 6 years of clinical execution experience OR
Bachelor’s degree and 8 years of clinicalexecution experience OR
Associate’s degree and 10 years of clinicalexecution experience OR
High school diploma / GED and 12 years of clinicalexecution experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 yearsexperiencedirectly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation orresources. Your managerial experience may run concurrently with the required technical experience referenced above
PreferredQualifications and Experience:
7 yearswork experience in life sciences industry, particularly focusing on clinical trial work, including 5 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 identifyoperational risks based on protocol design and implement innovative mitigation strategies. Identifyand manage study issues, communicatingand/or escalatingappropriately.
Strong collaboration and communication skills to engage with cross-functional teams, senior managementand external stakeholders, internally and externally
Interpretsclinical and operational data to guide trial execution and identifystudy trends. Collaborateswith biostatistics and data management to ensure data integrity
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/approvingsite expenditures, and optimizingresource allocation to ensure cost efficiencies
Able to identifyand implement opportunities for continuous improvement intothe team’s working practices
Strong understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles
Experience with overseeing external vendors (Contract Research Organizations, labs, imaging vendors, etc.) to drive and meet study deliverables with high quality
Navigates diverse regulatory, cultural, and operational environments. Buildsstrong relationships across geographies and time zones.
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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