Sr. Clinical Trials Business Systems Analyst

Katalyst Healthcares & Life Sciences

Remote, NJ(remote)

JOB DETAILS
SKILLS
Acceptance Testing, Administrative Skills, Biology, Biotech and Pharmaceutical, Business Administration, Business Analysis, Business Solutions, Business Strategy, Centralized Operations/Management, Change Management, Clinical Information Systems, Clinical Trial, Clinical Trial Management, Cross-Functional, Data Analysis, Data Cleaning, Data Modeling, Documentation, Establish Priorities, Functional Requirements Document (FRD), Functional Testing, Information Technology & Information Systems, Presentation/Verbal Skills, Process Development, Product Management, Requirements Management, Research & Development (R&D), Risk, Risk Analysis, Risk Management, Scripting (Scripting Languages), Systems Analysis, Time Management
LOCATION
Remote, NJ
POSTED
30+ days ago
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.
  • Ability to navigate complex challenge with a solution-oriented mindset.
  • Experience with communication and presentation to cross-functional audiences.

About the Company

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Katalyst Healthcares & Life Sciences