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IVD Clinical Trial Manager
2 months ago
Overview:
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development as an IVD Study Manager with Pathology experience.
Responsibilities:
- Leads the global study team with full accountability for the study with respect to quality, cost and timelines.
- • Develops study design for technical studies in coordination with internal/external experts and the development project team
- • Provides input to study synopsis prepared by CST for Clinical Utility and Clinical Performance studies and ensures that these Studies are planned and executed based on study synopsis with full responsibility for study protocol and study report
- • Ensures that all studies are planned, executed, monitored, closed out and documented in a competent and compliant way within the planned time frame and costs.
- • Ensures that the study results are continuously validated, assessed, clear recommendations drawn and communicated.
- • Oversight of data management processes, data quality and results, data base closure and reporting.
- • Ensures that data and reports which are necessary for the characterization, regulatory approval and marketing of the products have been agreed upon, made available and are documented in a timely fashion.
- • Ensures and is responsible that study results are presented or submitted for publication in alignment with publication plans
- • Planning of the study specific content and budget within the development project team and controlling the related agreed upon budgets during the study.
- • Managing study site and clinical study agreements
- • Delegation and oversight of tasks and work packages for internal and external collaborators within the study.
- • Planning, procurement, preparation and delivery of materials necessary for carrying out the study, in cooperation with the Study Support team.
- • Ensure compliance to all relevant safety and QM procedures in all studies.
Qualifications:
• Knowledge of applicable standards and regulations for clinical trial and lab conduct
• Proven oral and written communications skills
• Experience in all stages of international clinical study management, study protocol design, report writing and monitoring and leading local teams
• Proven planning, organizing, interpersonal and leadership skills
• Ability to work independently to make sound decisions and analyze and solve problems
• Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates
• Statistical knowledge
• Minimum - Bachelor's degree in medical technology, chemistry, biology or other science relevant field
