Senior Clinical Project Manager
New
Based in the United StatesFull-TimeManager
Salary125,000 - 175,000 USD per year
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Job Details
- Experience
- 10+ years of clinical research experience, including at least 7 years in clinical project management
- Required Skills
- Stakeholder management
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Health Sciences, or related field.
- 10+ years of clinical research experience, including at least 7 years in clinical project management within a CRO, pharmaceutical, or biotech environment.
- Strong expertise in managing Phase I–IV clinical trials, including oncology experience.
- Solid understanding of ICH guidelines and regulatory frameworks (FDA, EMA, Health Canada).
- Proven ability to lead cross-functional teams and manage multiple stakeholders in a matrixed environment.
- Strong financial acumen, including budgeting, forecasting, and scope/change management.
- Excellent communication, negotiation, and presentation skills with a proactive, solution-oriented mindset.
- Proficiency in project planning tools and structured project management methodologies.
Responsibilities
- Oversee end-to-end management of Phase I–IV clinical trials, ensuring adherence to timelines, budgets, SOPs, and global regulatory requirements (ICH, FDA, EMA, Health Canada).
- Coordinate cross-functional project teams including clinical operations, data management, biostatistics, regulatory, vendors, and medical writing to ensure seamless study execution.
- Develop, maintain, and track detailed project plans, budgets, resource allocations, and risk mitigation strategies using established project management tools and methodologies.
- Act as primary liaison with sponsors, managing communication, scope alignment, contract execution, change orders, and issue resolution.
- Monitor project performance through regular reporting, financial tracking, and milestone updates, escalating risks and deviations proactively.
- Facilitate project meetings, drive decision-making, and ensure timely follow-up on action items across internal and external stakeholders.
- Support RFI/RFP responses, project proposals, and business development opportunities as needed.
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