Director, Site Start Up

This is a fully remote position, open to applicants in Australia, +3 more countries.

📋 Description

• Offer guidance, leadership, and support to the SSU team for effective project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes.

• Assist in managing site start-up delivery encompassing IRB/Ethics Committee submissions, Competent Authorities submissions, governing bodies, site contracts, budget negotiations, and other start-up prerequisites.

• Develop the PFM SSU framework incorporating intelligence, tools, methodologies, risk evaluations, and mitigations.

• Collaborate with Clinical Operations, project management, and cross-functional departments on both global and regional SSU planning, execution, and governance.

• Support corporate and departmental business strategies.

• Advocate for change management to facilitate the evolution of PFM’s global structure and growth.

• Provide leadership and oversight for large and increasingly complex SSU programs.

• Manage SSU escalations and remediation effectively.

• Enhance processes and delivery to achieve or surpass budget targets.

• Collaborate with Global Resourcing teams to evaluate and manage SSU team members, ensuring cost, time, and quality objectives are met.

• Promote team career development, growth, and succession planning.

• Coordinate SSU Lead involvement in client meetings and presentations.

• Work with Business Development on opportunity development, proposals, budgeting, bid defense preparation, and attendance.

• Support SSU project strategy and delivery in conjunction with global and regional functional leaders.

• Assess SSU operations and implement necessary project modifications.

• Create, measure, and report on SSU KPIs while driving continuous improvement initiatives.

• Reinforce PFM’s culture and values to inspire, engage, and retain the SSU team.

• Ensure compliance of clinical trials with local and regional regulatory standards, ICH Guidelines, Good Clinical Practices, and SOPs.

⛳️ Requirements

• Bachelor's degree in life sciences or a related field, or equivalent combination of education, training, and experience.

• At least 12 years of experience in clinical research, with significant Site Start-up experience.

• Extensive leadership experience or demonstrated competencies relevant to the role.

• In-depth knowledge of GCP/ICH guidelines and the clinical development process.

• Proven leadership track record.

• Experience working within a team environment with resource management capabilities.

• Proficient in Microsoft Office applications: Outlook, Word, Excel, and PowerPoint.

• Familiarity with clinical software, including CTMS, eTMF, and EDC.

• Exceptional communication and interpersonal abilities.

• Strong organizational skills, meticulous attention to detail, and a customer service-oriented attitude.

• Proven experience in strategic planning, risk management, and change management.

• Proficiency in English.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Retirement savings plan with company match.

• Opportunities for professional development and continuous learning.

• Flexible work arrangements.

• Employee wellness programs.