We are looking for an experienced and versatile technical minded Clinical Sr. Business Analyst to be part of our talented project delivery team. The successful candidate will work as a key team member at to partner with our clients in the life sciences sector to define and deliver projects of varying levels of complexity and scope. You should demonstrate experience with GxP systems and creativity in application of processes as well as assessment methodologies. The ideal candidate has a strong track record of working in the Clinical operations systems landscape including CTMS and eTMF and has a solid working knowledge of the processes involved.

Responsibilities

• Demonstrate up-to-date expertise in GxP systems and apply this to the development, execution and improvement of client action plans by providing advice and guidance on approach and best practices.
• Identify, create, and facilitate process and system design by conducting business and systems process analysis and facilitating system requirements gathering sessions and authoring specification documentation; focusing on quality while partnering with clients to meet their business strategies.
• Liaise with technical resources to ensure design approach is flexible, scalable, and meets business requirements.
• Provide leadership and guidance to team members for end user testing processes by collaborating with others; articulating ideas and viewpoints to stakeholders; coordinating resources; driving the resolution of issues; and holding self and team accountable for results.
• Lead or participate in multiple projects by completing and updating project documentation; managing project scope; adjusting schedules when necessary; determining priorities; ensuring efficient and on-time delivery of project tasks and milestones; following proper escalation paths; and managing customer and partner relationships.
• Assess system(s) and process efficiency and functionality based on client objectives and end user engagement.
• Manage client relationships and expectations by developing a communication process to keep others up-to-date on project results.
• Stay current with customer needs and strategies; utilizing formal and informal written communication methods to communicate updates and findings; and facilitating project meetings and presentations to all types of diverse audiences across a given project.
• Coordinate efforts to analyze and update affected procedural documents (SOP, Work Instruction, Job Aids, etc.) in support of the implementation of clinical systems such as Veeva Vault.

Qualifications

• 7+ years of proven experience in IT or computer science or equivalent experience
• Knowledgeable of SDLC and the delivery of GxP Validated systems
• Experience with Veeva Vault configuration, implementation
• Practical experience generating process documentation and reports
• Excellent communicator with the ability to translate data into actionable insights
• Strong working knowledge of relevant Microsoft applications, including Visio
• Proven capabilities in project and user-acceptance-testing (UAT) management
• Highly proficient technical writing capabilities