Manager, Clinical Operations

ICON plc • Raleigh, NC

11d

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments toப் patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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)
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Responsibilities

• 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

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Manager