Senior Clinical Trials Project Leader

Planet Pharma; Melbourne; Presencial; AUD 140.000 - 190.000; Tempo integral

Resumo da vaga

Planet Pharma is seeking a Senior Project Manager – Clinical Trials to lead a portfolio of clinical studies across Australia. You will work closely with sponsors, CROs and investigators to ensure delivery, quality and strategic alignment.

In this role you will manage budgets, timelines and cross-functional teams, mentor project managers, and drive continuous improvement while ensuring ICH-GCP compliance and patient-centric trial delivery.

Qualificações

• Tertiary qualification in Life Sciences or Health Sciences.
• Strong knowledge of ICH‑GCP and clinical research regulations.
• Minimum 3 years’ experience in clinical trial project management or similar.
• Proven ability to lead multiple clinical trial projects concurrently.
• Excellent organisational, communication and stakeholder management skills.
• Strong financial acumen with study budgets experience.
• Experience leading teams in a fast-paced environment.

Responsabilidades

• Lead multiple clinical trial projects ensuring on-time, within-budget delivery.
• Develop and maintain detailed project plans, timelines and resources.
• Oversee study budgets, forecasting and financial performance.
• Manage sponsor, CRO, investigator and vendor relationships.
• Mentor and develop Project Managers and Associate PMs.
• Ensure ICH‑GCP compliance and continuous quality improvement.
• Drive patient recruitment strategies and enrolment targets.

Conhecimentos

Leadership

Project management

Stakeholder management

Communication

Financial acumen

Team development

Regulatory knowledge

Formação

Tertiary qualification in Life Sciences/Health Sciences

Descrição da vaga

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.