Manager, Study Start Up

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee daily site start-up and activation activities, ensuring your team delivers quality results.

• Manage and coordinate the complete study start-up process, including site selection, feasibility assessments, regulatory submissions, and site activation.

• Lead a team of study start-up professionals, offering guidance, mentorship, and support to ensure peak performance and successful project execution.

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

• Track study start-up metrics, timelines, and budgets to guarantee projects are completed punctually and within scope.

• Identify potential risks and challenges in the start-up process and implement strategies to mitigate delays or issues.

• Propel continuous improvement initiatives to refine the study start-up process and boost overall efficiency.

⛳️ Requirements

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

• Extensive experience in clinical trial study start-up, with a robust understanding of global regulatory requirements 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 managing multiple studies and priorities concurrently.

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

• Experience in process optimization and the application of best practices in study start-up activities.

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

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Learning and development opportunities through structured training and career pathways.