Lead Business Analyst – Clinical Trial Supplier Enablement

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: 

This role works at the intersection of clinical trial operations, technology, and external partnership and is critical for supporting the successful delivery of Amgen’s global clinical trials. 

As a Lead Business Analyst, you will act as a trusted technology partner to global clinical trial teams, enabling the effective use of Amgen technologies by specialist external suppliers. You’ll have responsibility for managing B2B solutions for one or more capability area and for overseeing activities of other Business Analysts.  

You’ll partner closely with clinical teams, product owners, technology partners, and external suppliers to translate complex business needs and problems into compliant, scalable, and sustainable solutions. 

Roles & Responsibilities:  

• Building and maintaining strong relationships across an extensive network of internal and external stakeholders. 

• Lead comprehensive business analysis to identify, understand and prioritize IT requirements in the product backlog. 

• Own the implementation and delivery of IT solutions and services for one or more supplier capability areas within product team. 

• Coordinating the activities of other analysts on the product team.   

• Ensuring IT solutions comply with regulations and information security policies. 

• Partnering with technology owners to deliver B2B connectivity, integrations and collaboration solutions. 

• Assessing new suppliers against Amgen’s IT requirements and documenting gaps and risks. 

• Supporting change management and end user communication for large user groups. 

• Maintaining accurate documentation of systems and processes. 

• Staying informed on the changing internal and external IT landscape and continue to evolve and adapt the IT solutions strategy to maximize effectiveness. 

Basic Qualifications and Experience:  

• Any degree with 8 - 13 years of experience working in Life Science, Biotechnology or Information Systems 

Functional Skills: 

Must-Have Skills: 

• A detailed understanding of the clinical trial process and the systems used to execute study delivery (EDC, CTMS, eTMF. et.c.) 

• Customer focused and a proven business relationship manager who is confident when working with technical and non-technical senior stakeholders. 

• Collaborative team player with excellent verbal and written communication skills; able to influence and lead effectively across global, cross-functional and remote stakeholders. 

• Experience of overseeing and coordinating the work of other Business Analysts 

• Ability to lead business analysis activities to capture and prioritize requirements through interviews and workshops. 

• Knowledge of B2B and integration technologies, including APIs, secure file transfers, VPN’s and Virtual desktops 

• Confident at documenting complex testable business requirements as clear user stories and in formal specification documentation. 

• Analytical, detail orientated with excellent problem-solving skills. 

• Experience of working with or as an external technical service supplier. 

• Practical experience and understanding of Agile methodologies, particularly the Scaled Agile Framework (SAFe) 

Good-to-Have Skills: 

• Experience of working with or for a clinical trial supplier (CRO, Lab, Imaging, e.t.c.)   

• Working in a regulated environment where compliance and information security is essential 

• Ability to Project manage complex longer term deliverables, 

• Proficiency in IT service delivery tools such as Jira, Jira Align, and Confluence. 

• An advocate of the use of DevOps, AI and Test Automation in delivery  

Professional Certifications (please mention if the certification is preferred or mandatory for the role): 

• Business Analysis certifications (IIBA BABOK) or similar (preferred)  

• Certified SAFe for Teams or similar (preferred) 

Soft Skills: 

• Excellent written and spoke English. 

• A people person, with excellent written and spoke English. 

• Highly accountable, reliable and proactive. 

• Able to self-manage activities across multiple priorities.