Manager, Clinical Operations
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Job Description
Manager, Clinical Operations leading integration of project team activities at ICON. Responsible for strategic study operations and vendor management for global clinical trials.
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
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)
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
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