We offer a full range of consulting, clinical development and commercialisation services from a global network of offices in 46 countries
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.
We are a global provider of co...
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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
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