Senior Clinical Trial Technology Imaging Manager
JOB SUMMARY:
The Senior Clinical Trial Technology Manager will be working cross-functionally with other teams to ensure that trials are executed consistently and efficiently as well as overseeing imaging vendors. Primary teams that this role will be collaborating with include Clinical Operations, Data Management, Biometrics, Clinical Supply, QA, Strategic Sourcing and Procurement, Clinical Programming, Clinical Development, and Clinical Science. This role is key in implementing and maintaining IxRS systems and other clinical technology suppliers to support clinical trials.
RESPONSIBILITIES:
- Lead Development and Documentation: Collaborate with internal stakeholders and technology suppliers to develop and document study-level business and system requirements.
- Governance and Oversight: Oversee and manage IxRS, Imaging, ECG, eCOA, and other clinical technology suppliers.
- Technical Oversight: Provide technical support for the design, implementation, and maintenance of IxRS to support clinical trials.
- Supplier Management: Define study parameters and requirements for RFPs and Scope of Work, and manage the evaluation, selection, and startup of technology suppliers.
- Stakeholder Representation: Represent the Clinical Trial Technologies group in study team meetings, data working groups, and project workstreams.
- Lead Implementation: Act as the primary stakeholder for implementing, maintaining, and closing out various clinical systems.
- User Requirements: Manage clinical technology suppliers to develop user requirements that meet business needs.
- Timeline Management: Coordinate with suppliers and internal teams to manage timelines and associated activities.
- Issue Resolution: Identify and track technical and escalated study-related issues to resolution.
- Communication Management: Facilitate communication and manage expectations between study teams, internal stakeholders, and clinical technology suppliers.
- Design Input: Provide input on IxRS design and specifications, and review supplier documents such as user requirements.
- User Acceptance Testing: Create test plans and conduct user acceptance testing (UAT) for IxRS and eCOA.
- Trend Analysis: Identify metrics and solutions for analyzing trends in potential and current issues.
- Performance Metrics: Collect, track, and analyze supplier performance metrics to ensure compliance with contract terms and performance goals.
- Protocol Deviation Oversight: Oversee imaging protocol deviations and manage SOP changes and deviation surveillance.
- Data Systems Audits: Perform periodic audits of clinical data systems.
- Records Retention: Support records retention management.
Education/Experience:
- BS/BA degree in related discipline and a minimum of nine years of related experience; or,
- MS/MA degree in related discipline and a minimum of seven years of related experience; or,
- PhD in related discipline and a minimum of two years of related experience; or,
- Equivalent combination of education and experience.
- May require certification in assigned area.
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