Partner with clinical and administrative stakeholders to gather, analyze, and translate business needs into clear, actionable user stories that contain functional and technical requirements.
Assess current clinical trials workflows and systems to identify opportunities for digital transformation, process optimization, and increased efficiency.
Facilitate stakeholder engagement through workshops, interviews, and focus groups to inform solution design and prioritization.
Serve as the primary liaison between business units and technical teams (including developers and QA) to ensure requirements are understood and accurately implemented. Lead or support quality assurance activities, including test planning, execution of user acceptance testing (UAT), and regression testing.
Design and deliver training materials and conduct user training sessions, including train- the-trainer programs.
Evaluate solution performance post-implementation and recommend iterative enhancements based on user feedback and business needs.
Create and manage reports, dashboards, and key performance indicators (KPIs) to support project tracking and data-driven decision-making.
Document and analyze current-state clinical workflows, systems, and processes to identify gaps, inefficiencies, and improvement opportunities.
Provide ongoing system support and act as a resource to ensure tools and solutions continue to meet evolving organizational requirements.
Qualifications:
Bachelor's degree required.
3-4 years of progressive experience in clinical trials at a healthcare institution, CRO, biopharma, or sponsor organization.
Experience working with PHI in an FDA-regulated environment.
Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
Strong interpersonal and communication skills with the ability to convey technical concepts clearly.
Demonstrated ability to work independently and collaboratively in a fast-paced team environment.
Highly organized, self-motivated, and detail oriented.
Strong problem-solving skills and ability to meet deadlines.
Comfortable learning new systems and tools.
Preferred Experience
Experience with diagramming tools such as Microsoft Visio or Lucidchart.
Familiarity with clinical trial technologies including EDMS, CTMS, EDC, EHR (EPIC).
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