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Posted 13 day(s) ago
Reference: 3195902525
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 RoleAs 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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.
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