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.
