Clinical Operations Lead (USA)

Excelya • Swiftwater, PA

2d

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; advanced degree is preferred.
• Fluent in English; 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

What This Job Offers

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