Lead Business Analyst - Clinical Trials and Technology Integration

Lead Business Analyst

Career Category

Business Development

Job Description

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 a cross 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 ownersto deliver B2B connectivity, integrations and collaboration solutions.

• Assessing new suppliers againstAmgen’sIT requirements anddocumenting gaps andrisks.

• Supportingchangemanagementandend user communication for largeuser groups.

• Maintainingaccurate 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 5 - 8 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 etc.)

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

• Collaborative team player withexcellentverbal and written communication skills; able toinfluence and leadeffectively 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 inaregulatedenvironment where compliance and information security is essential

• Ability toProject manage complexlonger termdeliverables,

• ProficiencyinIT servicedeliverytools such as Jira, Jira Align, and Confluence.

• An advocate ofthe useofDevOps,AIandTest Automation in delivery

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

• Business Analysis certifications (IIBABABOK) or similar (preferred)

• CertifiedSAFefor Teamsor similar (preferred)

Soft Skills:

• Excellent written and spoke English.

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

• Highly accountable, reliableand proactive.

• Abletoself-manageactivities acrossmultiple priorities.

Shift Information:

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

This rolehas global responsibilitieswhich may require flexibility with workinghourto align with keyglobalstakeholders

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 requestan accommodation.

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Experience Level

Senior Level