Senior Clinical System Lead at ICON plc

• As a Clinical System Lead you would lead and direct one or more project teams in the planning, development, implementation and go-live of clinical system solutions for our biotech and pharmaceutical customers.

Responsibilities:

• Serves as the primary contact for internal and external team members regarding clinical system development activities
• Tracks milestones, tasks and the overall budget for clinical system delivery
• Participates in Sponsor and/or third party audits
• Forecasts budget, hours and resourcing for clinical system development tasks
• Develops plans and oversees timelines for activities between receipt of protocol and go live of EDC and associated clinical system technologies
• Owns and is responsible for achieving on time release to production of the standalone and integrated clinical system technologies
• Responsible for documenting and overseeing implementation of changes to clinical system technologies
• Responsible for managing Third-Party technology providers and the setup of their systems within PRA
• Ensures quality-control steps are implemented so that quality deliverables are provided, including peer review of the eCRF
• Strong knowledge of Clinical Data Management Systems, computerized information systems and standard application software (Windows, MS Office)
• Strong knowledge of clinical data management
• Contributes to bid and proposal development and participates in bid defense

Experience:

• Minimum 3 years of project management experience required
• At least 2 years working in a CRO within the last 5 years is required
• Experience in leading 3 or more projects simultaneously
• Project management experience, including management of timelines, is essential
• Excellent communication skills
• Budget experience is required
• Experience with all steps within the data management lifecycle and most major data management study tasks, with proficiency in at least one Clinical Data Management system required. Familiarity with Rave is desired.
• Bachelor’s Degree (or international equivalent) OR equivalent work experience preferred