Sr. Clinical Trials Business Systems Analyst

Job Description:

• Work with GDO, R&D and cross-functional stakeholders to inform functional requirements for risk management tools within our direct, end client.
• Must required Experience on clinical trials and using/participating in study level risk assessments (not IT/System risk assessments).
• Partner closely with the Business System Owner for the system portfolio to capture the prioritization of functional requirements.
• Serve as a key contact for risk management applications including to inform system-level process definition, training development, and change management.
• Biotech / Pharmaceutical Experience a must!! This Is a Clinical Trials Systems Position.

• Document functional requirements for the system(s) in alignment with GDO/R&D business and strategic priorities.
• Partner with the Business System Owner to drive the functional prioritization of system requirements and capabilities and contribute to the development of the overall risk management technology roadmap(s).
• Partner with the Product Manager(s) to ensure functional requirements are translated to system requirements and planned for releases.
• Serve as primary contact for business-side system questions, coordinating with Business System.
• Own and other key stakeholders to find a timely and accurate resolution to questions.
• Drive business-side User Acceptance Testing of new system features and capabilities.
• This could include the creation of UAT scripts, coordination with functional UAT testers within the business, conducting UAT testing, documenting outcomes, and communicating to the product team.
• Responsible for fulfilling required business administration tasks and responsibilities including centralized Inbox management, data cleaning, and other data creation requests.
• Responsible for managing user access request forms including verification of training and access approval for risk tools.

• Bachelor's Degree or international equivalent preferred, advanced degree preferred.
• 5+ years of experience in business analysis, data analysis, data transfer, data model roles or 6+ years relevant experience in lieu of Bachelor's Degree or international equivalent.
• 3+ years of experience in the life sciences preferred, with experience in clinical trial management/operations preferred.
• Experience with clinical trial operational systems, clinical trial risk systems a plus.
• Expert level expertise with product management and requirements elicitation.
• Demonstrated experience working in a matrixed environment and navigating complex issues/situations with vendors to achieve business results.
• Ability to navigate complex challenge with a solution-oriented mindset.
• Experience with communication and presentation to cross-functional audiences.