Project Manager – Early Phase

This is a fully remote position, open to applicants in Australia.

📋 Description

• Develop, execute, and finalize research projects in alignment with project specifications.

• Lead and facilitate cross-functional project teams.

• Manage communication and relationships with clients.

• Oversee project finances and ensure successful study delivery.

• Guarantee effective resource allocation, efficient management, budget compliance, timeline adherence, and adherence to GCP, regulatory standards, and SOPs.

• Mentor and coach junior project management personnel or Clinical Delivery Leads.

• Create project plans and internal project management documentation.

• Coordinate feasibility studies, site selection, and vendor selection processes.

• Monitor project scope, budgets, forecasts, invoicing, milestones, and timelines.

• Supervise clinical site setup and management activities.

• Manage project administration, meetings, and newsletters.

• Ensure the delivery of clean, accurate, and verifiable data.

• Review and approve monitoring visit reports.

• Safeguard patient safety and ensure regulatory reporting of adverse events.

• File and archive clinical project data and study documentation.

• Coordinate study initiation, ethics and regulatory submissions, investigator meetings, and monitoring plans.

• Oversee study close-out visits and final reconciliation and archiving processes.

• Ensure data collection is accurate, complete, and timely, and manage query resolution.

• Analyze financial reports, manage forecasts, margins, pass-through billing, and scope adjustments.

• Maintain relationships with stakeholders, including sponsors, hospitals, professional societies, and associations.

• Participate in bid defense presentations and contribute to scope change proposals.

• Ensure project audit readiness and compliance with quality management requirements.

⛳️ Requirements

• Bachelor’s or Master’s degree in a scientific or related field.

• Prior experience in clinical projects within an academic, CRO, or pharmaceutical company setting.

• Approximately seven (7) years of experience in the industry.

• 1-2 years of experience in Project Management.

• Previous CRA experience preferred, or experience in site management, trial coordination, or relevant industry experience is required.

• Experience managing projects across single or multiple regions.

• Familiarity with various therapeutic indications.

• Experience overseeing full-service studies.

• Experience working on early-phase clinical trials.

• Strong understanding and ability to implement project activities according to ICH/GCP and all applicable regulations and guidelines in relevant regions.

• Previous exposure to client-facing roles and/or client management.

• Experience in project finance management.

• Excellent interpersonal, presentation, and team leadership skills, including the ability to lead virtual teams in a multicultural environment and handle conflicts.

• Strong written and verbal communication abilities, with exceptional presentation skills.

🏝️ Benefits

• Competitive Compensation: A customized salary and benefits package that reflects your skills and experience.

• Flexibility: Options for hybrid or remote working arrangements based on your location and role.

• Career Growth: Access to extensive learning opportunities and a global network of scientific leaders.

• Employee Wellbeing programs and initiatives that promote work-life balance, health, and team connectivity.

• Global engagement surveys.

• Recognition programs.

• Team-building events.

• Opportunities for global exposure and diverse projects with various clients.

• Purpose-driven work that contributes to clinical trials aimed at improving lives.

• A culture that values collaboration and innovation, fostering diverse perspectives and creative solutions.