Study Start Up Manager, Sponsor Dedicated

Role Overview

• Manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes.
• Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation.
• Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery.
• Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation.
• Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope.
• Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues.
• Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency.

Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations.
• Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment.
• Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously.
• Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams.
• Experience with process optimization and implementing best practices in study start-up activities.
• Willingness to travel as required (approximately 25%)

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.