Clinical Operations Lead at Excelya enhancing clinical research strategies in the U.S. market and driving operational excellence with a dedicated team.
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
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.
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