APX Life SciencesRemote
Senior Clinical Project Manager - Ophthalmology & Oncology
United States of America
Full Time
3 weeks ago
Visa Sponsor
Key skills
Project ManagementRisk ManagementBudgeting
About this role
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 role involves managing a pivotal trial from initiation to closeout while also overseeing a team of Clinical Research Associates.
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
Requirements:
- 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