Clinical Operations Lead (USA)

Excelya • Swiftwater, PA

17h

About The Position

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy . As a Clinical Operations Lead (USA), you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies in the vibrant U.S. market. This position offers a unique opportunity to lead a dedicated team while collaborating with various stakeholders to uphold the highest standards of quality in clinical operations. You will be instrumental in driving innovation and contributing to cutting-edge research initiatives that shape the future of healthcare.

Requirements

• At least 5 years of experience in clinical operations as project manager within a CRO or pharmaceutical environment, including prior leadership responsibilities.
• In-depth knowledge of clinical trial methodologies, regulatory standards, and GCP
• exceptional leadership and communication skills with the ability to foster positive relationships.
• Master’s degree in life sciences or a related field
• Fluent in English

Nice To Haves

• advanced degree is preferred.
• proficiency in additional languages is a plus.

Responsibilities

• Coordinate and support clinical project teams, including identification and alignment of Clinical sub-team members
• Actively contribute to project and clinical team meetings, ensuring effective follow-up and communication
• Coordinate Clinical sub-team meetings and ensure action tracking and issue resolution
• Lead coordination of Clinical CTD task forces and contribute to PAI preparation, conduct, and closure
• Collaborate closely with GCDSE on project execution, team organization, and governance
• Ensure clear team direction, alignment with franchise and project strategy, timeline adherence, and proactive risk and escalation management
• Contribute to clinical operational strategy documents (e.g. TPP, CDP)
• Use clinical project analytics to identify, monitor, and communicate risks, issues, and alerts
• Ensure timely and accurate planning and reporting, including project plans, timelines, budgets, and operational updates
• Support platform and organizational initiatives by contributing to process improvement, acting as a subject matter expert, and delivering training related to job certification

Benefits

• At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
• We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience .
• Our one-stop provider service model —offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects.
• Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
• Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager