Study Start-Up Manager

This is a fully remote position, open to applicants in North Carolina, +2 more states.

📋 Description

• Oversee daily site start-up and activation tasks, assisting the team in achieving quality results.

• Manage the comprehensive study start-up process, encompassing site identification, feasibility assessments, regulatory submissions, and site activation.

• Lead a team of professionals focused on study start-up, offering guidance, mentorship, and support.

• Collaborate with sponsors, clinical operations, and regulatory teams to ensure adherence to local and global regulations and timelines.

• Track study start-up metrics, timelines, and budgets effectively.

• Recognize risks and challenges within the start-up process and apply mitigation strategies.

• Promote continuous improvement initiatives aimed at optimizing the study start-up process and increasing efficiency.

⛳️ Requirements

• A bachelor's degree in a relevant scientific discipline or a healthcare-related field.

• Substantial experience in clinical trial study start-up, with a deep understanding of global regulatory standards and clinical operations.

• Demonstrated leadership abilities, with experience in managing and mentoring teams within a fast-paced, deadline-oriented environment.

• Exceptional organizational and project management skills, capable of juggling multiple studies and priorities simultaneously.

• Strong communication and stakeholder management capabilities, with the ability to collaborate effectively with sponsors and internal teams.

• Experience in process optimization and the implementation of best practices in study start-up activities, along with the development and execution of SSU plans.

• Willingness to travel as necessary (approximately 25%).

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.