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.
Clinical Project Manager leading the planning and execution of Global Drug Development studies for Novartis in China. Collaborating with various teams to ensure compliance and timely delivery of studies.
Regional Vice President of Clinical Operations overseeing dialysis business at Fresenius Medical Care. Directing customer service, quality care, financial performance, and operational efficiency.
Associate Director at Verastem Oncology overseeing phase 3 global clinical trial. Leading operational execution and compliance with regulatory guidelines for oncology - focused studies.
Clinical Project Manager II managing biomarker studies for clinical trials at Syneos Health. Overseeing operations, ensuring project success, and providing leadership to cross - functional teams in a fully remote role.
SSO Study Start - Up Manager guiding study planning and activation deliverables across various regions. Ensures compliance with regulatory requirements and collaboration with global study teams.
Head of AI Transformation & Enablement for Global Clinical Operations defining AI strategy and leading AI transformation initiatives in Switzerland's healthcare sector.
Immunology Therapeutic Area Lead driving early development strategies for immunology therapeutics with cross - functional teams. Leading strategic planning and operational oversight for clinical programs.
Manager/Director of Clinical Operations overseeing clinical trials at ERG in Miami, FL. Responsible for protocol adherence and operational management of studies.
Scientist contributing to the scientific planning and execution of clinical trials within the ophthalmology field. Developing leadership, technical skills, and scientific acumen in a global team context.