Senior Project Manager – Clinical Trials

About the Opportunity

Our client is a fast-growing clinical research organisation committed to advancing clinical trial delivery across Australia. Through innovative and patient-centric approaches, they partner with sponsors, CROs, investigators and healthcare providers to deliver high-quality clinical research programs.

Due to continued growth, an exciting opportunity has arisen for an experienced Senior Project Manager to lead a portfolio of clinical trials and provide leadership to a team of Project Managers and Associate Project Managers.

The Role

As a Senior Project Manager, you will be responsible for the successful delivery of multiple clinical trial projects, ensuring operational excellence, financial oversight, stakeholder satisfaction, and team leadership.

You will act as a key liaison between sponsors, CROs, vendors, investigators and internal teams, while driving project performance, quality outcomes and continuous improvement initiatives.

Key Responsibilities

Project Leadership & Delivery

• Lead multiple clinical trial projects simultaneously, ensuring studies are delivered on time, within budget and in accordance with quality standards.
• Develop and maintain detailed project plans, timelines and resource allocation plans.
• Act as the primary escalation point for project-specific issues and study deliverables.
• Review new study opportunities and provide operational feasibility input.
• Support study start-up activities, including budget development and contract-related operational planning.
• Ensure effective communication and collaboration across cross-functional teams and external stakeholders.

Financial & Portfolio Management

• Maintain oversight of study budgets, forecasting and financial performance.
• Monitor project expenditure against approved budgets and contracts.
• Ensure accurate and timely study billing and invoicing processes.
• Track portfolio performance and identify financial risks, implementing mitigation strategies where required.
• Support revenue forecasting and reporting activities.

Stakeholder Management

• Build and maintain strong relationships with sponsors, CROs, investigators, vendors and internal stakeholders.
• Provide regular project updates and performance reporting.
• Proactively manage stakeholder expectations and resolve issues in a timely manner.
• Gather and act on sponsor feedback to drive service excellence and continuous improvement.

People Leadership

• Lead, mentor and develop Project Managers and Associate Project Managers.
• Drive performance, engagement and career development across the project management team.
• Support workforce planning, succession planning and talent development initiatives.
• Ensure new team members receive effective onboarding and role-specific training.

Quality & Compliance

• Ensure projects are conducted in accordance with ICH-GCP, applicable regulations and internal procedures.
• Support CAPA management, quality initiatives and continuous improvement activities.
• Participate in the development and review of SOPs, guidelines and operational processes.
• Conduct periodic project reviews and audits to ensure compliance and operational excellence.

Patient Recruitment & Retention

• Support patient recruitment strategies across studies.
• Monitor recruitment performance and identify risks to enrolment targets.
• Collaborate with operational teams and external referral networks to optimise participant engagement and retention.
• Ensure a positive participant experience throughout the clinical trial lifecycle.

What We’re Looking For

Essential Requirements

• Tertiary qualification in Life Sciences, Health Sciences or a related discipline.
• Strong knowledge of ICH-GCP and clinical research regulations.
• Minimum 3 years’ experience in clinical trial project management or a similar leadership role.
• Demonstrated experience managing multiple clinical trial projects concurrently.
• Excellent organisational, communication and stakeholder management skills.
• Strong financial acumen with experience managing study budgets and project profitability.
• Proven ability to lead, mentor and develop high-performing teams.
• Ability to work effectively in a fast-paced and evolving environment.

Desirable Requirements

• Experience managing Phase I or First-in-Human clinical trials.
• Previous experience within a pharmaceutical, biotechnology, CRO or clinical research environment.
• Postgraduate qualifications in Business, Management or Project Management.
• Experience working within TGA, FDA and/or EMA regulated environments.

Key Competencies

Successful candidates will demonstrate:

• Strong leadership and team development capabilities.
• Strategic thinking and commercial awareness.
• Excellent relationship-building and influencing skills.
• High levels of accountability and ownership.
• Strong problem-solving and decision-making abilities.
• Exceptional communication and stakeholder engagement skills.
• A continuous improvement mindset with a focus on quality and operational excellence.