Project Manager, Trial Lead - FSP

• Serve as the primary project-level contact between the sponsor and the organization
• Ensure internal and external escalation pathways and communication rules are followed
• Define responsibilities and communication pathways for secondary project leads when required
• Own overall cross-functional project delivery for time, cost, and quality
• Manage project-level financial stewardship, including contract understanding, resource-to-budget alignment, out-of-scope activity, change-order negotiations, and team execution timelines
• Establish, communicate, and manage customer expectations
• Drive project-level risk identification and issue resolution using RBQM/RESOLVE
• Ensure project team compliance with organizational policies, SOPs, ICH-GCP, regulatory requirements, and project-specific requirements
• Lead cross-functional project teams to meet or exceed deliverables

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 6+ years in clinical operations management, managing clinical trials according to quality, timeline, and budget expectations
• Technical and systems competency, including Microsoft Outlook, Word, Excel, PowerPoint, CTMS, Preclarus, and Clarity
• Ability to delegate and prioritize own workload and project team members' workload in a frequently changing environment
• Effective oral and written communication and presentation skills
• Advanced therapeutic area knowledge and clinical development guidelines and directives
• Strong understanding of project management principles: time, quality, and cost
• Solid financial acumen
• Interpersonal and customer service skills, including leading, motivating, and coordinating cross-functional project teams
• Judgment, decision-making, critical thinking, analytical thinking, and strategic thinking skills
• Ability to negotiate, persuade, and influence others
• Cross-cultural awareness
• Compliance with organization policies, SOPs, ICH-GCP, regulatory, and project-specific requirements
• Willingness and ability to work in an office, laboratory, and/or clinical environment
• Ability to work with potential exposure to biological fluids, infectious organisms, and electrical office equipment
• Ability to use required personal protective equipment, including protective eyewear, garments, and gloves

• Global team environment
• Collaboration and development opportunities
• Opportunity to contribute to scientific excellence and innovation