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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.
Job Responsibility
Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge
Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies
Provide input into global subject/patient recruitment plans
Relationship management between study sites and vendors
Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight
Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc
Create and update critical trial-specific documents (for example country specific ICF) and plans
Support development of compound and protocol level training materials
Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
Interface with internal key stakeholders including, but not limited to
Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs
which may include acting as a liaison between groups
Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level
Participate in process improvement activities at a trial and department level as needed
Requirements
BS/ BA Degree is required
5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials
2-3+ years leading aspects of global clinical trials
Experience working with a CRO
Strong regulatory knowledge, including Good Clinical Practices (GCPs)
Strong decision-making, analytical and financial management skills are essential to this position
Proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
Experience in leading without authority and in multifunctional matrixed and global environments
Experience mentoring/ coaching others
Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability
Strong project planning/ management, communication (written and verbal) and presentation skills
Experience with protocol, ICF, CRF, CSR development and review
Proficient with MS Office Suite (Excel, Word and PowerPoint)
What we offer
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others