Senior Clinical Project Manager / Clinical Project Manager

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

📋 Description

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

• Act as the main point of contact and escalation point for the client.

• Manage and supervise functional services and external vendors in line with timelines and budgets.

• Oversee study budgets, scope, out-of-scope activities, and change orders from initiation to execution.

• Collaborate with clinical operations and engage in clinical activities as necessary.

• Ensure the financial viability of the study, including project profitability, billable hours, billing, and forecasting.

• Create detailed project plans, timelines, and strategies for risk management and mitigation.

• Maintain quality management, eTMF inspection readiness, quality notifications, and CAPAs.

• Work with functional operations and review study documentation.

• Develop metrics to track trial and team progress.

• Generate project status updates and communicate KPIs, progress, solutions, and opportunities to clients and senior management.

• Facilitate internal and client meetings, establishing clear expectations for the project team.

• Address protocol and study issues, deviations, and necessary actions with clients and Precision management.

• Deliver formal presentations, including bid defenses.

• Implement and oversee compliance with study-specific training.

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

• Provide continuous feedback and conduct annual performance reviews for team members in functional roles.

• Fulfill assigned responsibilities, complete organizational training, time reporting, and meet administrative requirements.

⛳️ Requirements

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

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

• Minimum of 4 years in direct project management.

• Experience in managing complex and global trials.

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

• Proficiency in Microsoft Office Products (Outlook, Word, Excel, PowerPoint).

• Familiarity with Microsoft Project.

• Experience with eTMF, EDC, and CTMS.

• Knowledge of ICH-GCP guidelines and applicable Precision SOPs.

• Proven expertise in project management techniques and tools.

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

• Understanding of cross-functional management principles.

• Insight into project planning, risk management, and change management.

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

• Demonstrated skills in time management, negotiation, critical thinking, decision-making, analytical thinking, and interpersonal relations.

• Strong presentation skills and proficiency in verbal and written communication.

• Familiarity with project management software.

• Extensive experience in pharmaceutical and/or device research.

• An advanced degree is preferred.

🏝️ Benefits

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

• Employee contributions are valued, with input and ideas encouraged and supported.

• Commitment to equal opportunity employment.

• Reasonable accommodation assistance for applicants with disabilities.