Lead Business Analyst, Clinical Informatics

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Job description

Job Description

Digital
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The Role:

This role is an exciting opportunity to be a critical part of Clients growing Clinical and Medical Digital Systems Team, supporting a high-growth organization that is radically changing the biotech industry.

The Business Analyst will support the requirement gathering and implementation of Clinical and Medical Digital systems. A practitioner of agile and an expert in modern requirement gathering practices such as design thinking, and user centered design. The Business Analyst will excel at distinguishing the needs and the wants of end users articulating those in clear and concise artifacts support the definition and implementation of leading digital medical and clinical systems.

Heres What Youll Do:

Partner with clinical operations, data management, biostats, clinical supplies organization, medical affairs, regulatory and safety to execute on Client leading edge digital and analytics strategy to support accelerated drug development.

Lead user centered design workshops for the collection and improvement of personas, epics and user stories.

Author requirement documents: epics, user stories and associated functional and design documents

Collaborate with data engineering, informatics and data science team to develop modern analytics applications

Engage with digital integration engineering team, business and quality systems teams to implement cross-functional integrations and support our digital integrated landscape

Participate in the authoring of validation artifacts for user acceptance testing and procedural documents (SOPs)

Support product owners in product backlog grooming and release definition

Heres What Youll Bring to the Table:

Fundamentally you are a business analyst who enProducts interacting with your end users and can drive product definition and execution in a fast-moving digital organization. You understand and practice lean and user centered design methodologies. You are passionate about drug development and bringing new medicines to patients.

At least 5 years experience in the definition, design, implementation and support of solutions in one or multiple clinical and medical systems such as CTMS, site engagement portals, clinical operations metrics and analytics. Experience in decentralized clinical trials platforms would be a plus.

You have a proven experience with external vendor integration (CRO, central labs, imaging labs etc.) and vendor technology management

Experience with Computerized System Validation and global regulatory requirements for data privacy and protection (GDPR)

Tangible record of accomplishment in using Agile approaches for product development

Demonstrable experience in Design Thinking.

Working knowledge of cloud-based requirement management and agile process management tools (Jira, Confluence, Asana or similar)

As a technologist, you know your craft and, you are fluent in the digital world. You have first-hand knowledge of technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.

You have a working knowledge of clinical operations processes in a drug development context

You work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward.

You don't hesitate to dive in and work alongside the team. You can effectively manage conflicting priorities in a fast pace environment, and you can navigate ambiguity effectively.

You put team before tasks by collaborating actively with all team members and supporting them.

A desire to be part of a high-growth, transformational company that is Product, Relentless, Curious, and Collaborative

Bachelor's degree in Computer Science, Biotechnology or equivalent required.