Senior Clinical Project Manager

This is a fully remote position, open to applicants in Australia, +3 more countries.

📋 Description

• Plan, lead, coordinate, and execute activities for assigned clinical study projects.

• Act as the primary contact and escalation point for clients.

• Oversee and coordinate functional services and external vendors in line with timelines and budgets.

• Manage study budgets, scope, change orders, profitability, billable hours, billing, and forecasting.

• Collaborate with clinical operations and functional teams for successful study delivery.

• Create project plans, timelines, and proactive risk mitigation strategies.

• Ensure quality management, eTMF inspection readiness, quality notifications, and CAPA plans.

• Establish tracking metrics to monitor trial and team progress.

• Prepare project status updates and report key performance indicators to clients and senior management.

• Lead internal and client meetings, setting clear expectations for the project team.

• Communicate protocol and study-related issues, deviations, and necessary corrective actions.

• Conduct formal presentations, including those for bid defenses.

• Implement and oversee study-specific training compliance.

• Assist in business development and marketing efforts, including travel to bid defense meetings.

• Provide ongoing feedback and conduct annual performance reviews for functional team members.

• Complete necessary training, time reporting, administrative tasks, and other assigned duties.

⛳️ Requirements

• Bachelor’s degree or an equivalent combination of education and experience in a science or health-related field.

• An advanced degree is preferred.

• At least 7 years of clinical research experience or demonstrated competencies for this role.

• Minimum of 4 years of direct project management experience.

• Experience in managing complex and global trials.

• Willingness to travel domestically and internationally, including overnight stays.

• Proficiency with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and Microsoft Project.

• Familiarity with eTMF, EDC, and CTMS.

• Knowledge of ICH-GCP and relevant Precision SOPs.

• Experience with project management techniques and tools.

• Direct experience in a global, cross-functional project management environment.

• Understanding of cross-functional management.

• Experience in project planning, risk management, and change management.

• Extensive proven experience in pharmaceutical and/or device research.

• Strong communication, organizational, presentation, analytical, interpersonal, negotiation, critical thinking, decision-making, and time-management skills.

• Proven knowledge of project management software.

🏝️ Benefits

• Ability to work remotely from Australia, Singapore, South Korea, or Taiwan.

• Opportunity to contribute to life-changing therapies and positive change within the company.

• Employee appreciation and recognition of valued input.

• Commitment to equal opportunity employment.

• Reasonable accommodations available for applicants with disabilities.