Senior Program Manager (Clinical)
Location
United States
Posted
4 days ago
Salary
Not specified
No structured requirement data.
Job Description
- Bachelor's degree in business, management, or a related field; Master's degree preferred.
- Minimum 10 years of project management experience, with at least 5 of clinical program management.
- Project Management Professional (PMP) certification or equivalent preferred.
- Strong organizational, analytical, and problem-solving skills.
- Excellent verbal and written communication skills.
- Proven ability to manage multiple projects simultaneously in a fast-paced environment.
- Proficiency in project management software and tools.
Competencies
- Leadership and cross-functional team management
- Strategic thinking and decision making
- Clinical and regulatory acumen (ICH-GCP, FDA/EMA expectations)
- Vender and CRO management effectiveness
- Quality focus, audit readiness, and compliance mindset
- Adaptability and resilience
- Stakeholder engagement
- Conflict resolution and negotiation
- Attention to detail
- Develop comprehensive project plans, including timelines, resource allocation, and risk management strategies.
- Lead cross-functional teams across Clinical Operations, Biostatistics, Regulatory, Medical Affairs, Supply Chain and Quality to drive successful execution of Clinical Development programs.
- Oversee planning and delivery of clinical trials, ensuring adherence to study protocols, regulatory requirements, GCP, and patient safety standards.
- Manage vendor relationships—including CROs, central labs, and technology partners—ensuring high-quality deliverables and timely performance.
- Partner with Clinical Development leadership to align project strategy, study design, and timelines with program objectives.
- Identify and mitigate clinical, operational, and regulatory risks that could impact study execution or milestones.
- Ensure accurate forecasting and tracking of clinical trial budgets, including site costs, monitoring, data management, and third‑party services.
- Drive inspection readiness and support internal and external audits related to clinical studies.
- Facilitate communication and decision-making by providing updates on study progress, enrollment, safety signals, and key metrics.
- Champion process improvements and best practices specific to clinical trial delivery and protocol optimization.
- Ability to effectively communicate across multiple levels of the organization
- Competitive salary and benefits package.
- Opportunities for professional development and career growth.
- Collaborative and innovative work environment.
Disclaimer:
The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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