Note: The job is a remote job and is open to candidates in USA. APX Life Sciences is partnered with a fast growing mid-sized CRO seeking a Senior Clinical Project Manager to lead a global study in Ophthalmology and support an Oncology program. This hands-on role involves managing pivotal trials and growing a team of CRAs.

Responsibilities

• Lead cross-functional project teams (Clinical Operations, Data Management, Biostats, Pharmacovigilance, etc.) to execute the project according to the contract and protocol
• Develop and maintain essential project management documentation, including the Project Management Plan, Project Schedule, and Risk Management Plan
• Proactively identify risks and implement mitigation strategies to keep projects on track
• Oversee site selection, initiation, monitoring, and closeout phases
• Serve as the primary liaison between the CRO and the Sponsor, building trust and ensuring high levels of client satisfaction
• Lead client meetings and present project status updates, including key metrics and performance indicators
• Manage scope changes effectively, utilizing the Change Order process to protect the CRO’s profitability
• Manage project budgets, track actuals against forecasts, and ensure optimal resource allocation
• Review and approve invoices, timesheets, and vendor contracts related to the project
• Support the Business Development team in proposal development (budgeting and timeline strategy) for new opportunities
• Mentor and provide guidance to Clinical Research Associates
• Contribute to the development and refinement of departmental SOPs and best practices

Skills

• Bachelor's degree in Life Sciences, Nursing, or related field
• Minimum 5-7 years of clinical research experience, with at least 3-4 years of dedicated Project Management experience within a CRO environment
• Proven track record of successfully managing global or multinational Phase II-III trials
• Must have experience with Ophthalmology and Oncology
• Advanced degree preferred

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