Director, Site Start Up

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

📋 Description

• Lead and provide comprehensive support to the Site Start-up team throughout project execution, communication, human resource management, revenue enhancement, procedures, systems, and processes.

• Assist in the management of site start-up delivery, encompassing IRB/Ethics Committee submissions, Competent Authority submissions, site contracts, budget negotiations, and other necessary start-up elements.

• Develop the Precision for Medicine Site Start-up framework, integrating intelligence, tools, methodologies, risk assessments, and mitigation strategies.

• Collaborate with Clinical Operations, project management, and various cross-functional departments in global and regional Site Start-up planning, execution, and governance.

• Aid in the support of corporate and departmental business strategies and change management for organizational growth and expansion.

• Provide leadership and oversight for complex Site Start-up programs.

• Address escalations and remediation of Site Start-up issues.

• Streamline processes and delivery to enhance profitability and meet budget targets.

• Partner with Global Resourcing to evaluate and manage Site Start-up leads, specialists, and site contract management personnel.

• Support the career development, growth, succession planning, and adherence to company policies and regulatory standards for the team.

• Coordinate the participation of Site Start-up Leads in client meetings and presentations.

• Collaborate with Business Development on opportunity growth, proposals, budgeting, bid defense preparation, and attendance.

• Assist in the Site Start-up project strategy and delivery alongside global and regional functional leaders.

• Assess Site Start-up activities and implement necessary project modifications.

• Develop, measure, and report on Site Start-up KPIs while leading continuous improvement efforts.

• Promote company culture and values, inspire the team, sustain engagement, and enhance retention.

⛳️ Requirements

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

• At least 12 years of experience in clinical research, with a strong focus on Site Start-up.

• Significant leadership experience or proven competencies for this role.

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

• Proven track record of leadership effectiveness.

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

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

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

• Exceptional communication and interpersonal skills to effectively engage in a team context.

• Strong organizational capabilities, meticulous attention to detail, and a customer service-focused attitude.

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

• Proficiency in English.

🏝️ Benefits

• Comprehensive health insurance options.

• Opportunities for professional development and career advancement.

• Flexible working arrangements.

• Competitive salary and performance-based bonuses.

• Supportive work environment that values diversity and inclusion.