Senior Program Manager (Clinical)
PKR
Job Description
Job Description
Who Our Client Is
Our client is a purpose-driven medical device organization dedicated to improving patient outcomes through innovation, quality, and integrity. They foster a collaborative environment where expertise is valued, ideas are welcomed, and teams work together to deliver meaningful impact.
What Our Client Needs
Our client is seeking a Senior Program Manager, Clinical to lead complex clinical development programs from strategy through execution. This role drives cross-functional alignment and ensures clinical trials are delivered on time, within scope, and within budget.
Who You Are
You are a strategic leader with deep clinical program management experience. You bring strong regulatory acumen and a quality-first mindset. You communicate clearly across all levels of the organization and thrive in fast-paced environments. You are organized, decisive, and skilled at managing risk, vendors, and competing priorities.
What You’ll Do
• Develop comprehensive program plans including timelines, resource allocation, and risk management strategies
• Lead cross-functional teams across Clinical Operations, Biostatistics, Regulatory, Medical Affairs, Supply Chain, and Quality
• Oversee planning and execution of clinical trials in compliance with study protocols, ICH-GCP, FDA and EMA expectations, and patient safety standards
• Manage vendor and CRO relationships to ensure high-quality deliverables and on-time performance
• Partner with Clinical Development leadership to align study design, timelines, and strategy with program objectives
• Identify and mitigate clinical, operational, and regulatory risks that could impact milestones
• Forecast and track clinical trial budgets including site costs, monitoring, data management, and third-party services
• Drive inspection readiness and support internal and external audits
• Provide clear updates on study progress, enrollment, safety signals, and key metrics to support decision-making
• Champion process improvements and best practices in clinical trial delivery and protocol optimization
What You’ll Need
• Bachelor’s degree in Business, Management, or related field
• Master’s degree preferred
• Minimum 10 years of project management experience, including at least 5 years in clinical program management
• PMP certification or equivalent preferred
• Strong knowledge of ICH-GCP and FDA or EMA regulatory expectations
• Experience managing vendors and CROs
• Strong organizational, analytical, and problem-solving skills
• Excellent verbal and written communication skills
• Ability to manage multiple complex projects simultaneously
• Proficiency in project management software and tools
What They Offer
• Opportunities for professional development and career growth
• Collaborative and innovative work environment
• Medical, Dental, and Vision Insurance
• Life and AD&D Insurance
• Short- and Long-Term Disability Coverage
• 401(k) with generous company match
• Health Savings Account (HSA) and Flexible Spending Account (FSA) with company match
• Wellness Program and Employee Assistance Program (EAP)
• Generous Paid Time Off (PTO)
Equal Opportunity Statement
Our client believes that diversity fuels innovation, strengthens teams, and drives success. They are committed to fostering a workplace where every individual—regardless of background—feels valued, respected, and empowered to thrive. Discrimination or harassment of any kind is strictly prohibited.
Our client does not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by applicable laws. Their commitment extends beyond compliance; they actively cultivate an inclusive culture where diverse perspectives are welcomed, and every employee has an equal opportunity to contribute and succeed.
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