Bachelor's degree or equivalent; advanced degree preferred.
5+ years in business or data analysis, or 6+ years relevant experience without a degree.
3+ years in life sciences, specifically in clinical trial management.
Experience with clinical trial operational systems and risk systems is advantageous.
Expertise in product management and requirements elicitation essential.
Proven ability to navigate matrixed environments and complex issues.
Strong communication and presentation skills for cross-functional audiences.
Responsibilities
Document functional requirements aligned with GDO/R&D strategic priorities.
Collaborate with the Business System Owner to prioritize functional system requirements.
Work with Product Manager(s) to translate functional to system requirements.
Act as main contact for business-side system queries, ensuring resolutions.
Oversee User Acceptance Testing (UAT) processes and documentation.
Create UAT scripts and coordinate with testers for effective testing outcomes.
Manage user access requests and verify necessary training and approvals.
Benefits
Opportunity to work with cross-functional stakeholders in crucial risk management processes.
Exposure to clinical trials and biotech/pharmaceutical environments.
Chance to influence the development of technology roadmaps for risk management.
Role offers engagement with advanced system features and capabilities through UAT.
Develop valuable expertise in risk management applications and business administration tasks.
Full Job Description
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.
Responsibilities:
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.
Requirements:
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.
bility to navigate complex challenge with a solution-oriented mindset.
Experience with communication and presentation to cross-functional audiences.
