Manager, Study Start Up

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

📋 Description

• Oversee daily site initiation and activation tasks.

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

• Lead a team of start-up professionals by providing 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.

• Identify potential risks and challenges during the start-up phase and develop mitigation strategies.

• Propel continuous improvement initiatives to enhance the efficiency and effectiveness of study start-up processes.

⛳️ Requirements

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

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

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

• Excellent organizational and project management capabilities, with the aptitude to manage multiple studies and priorities concurrently.

• Strong communication and stakeholder management skills, 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.

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

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

🏝️ 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 insurance and disability coverage.

• Employee assistance programs and wellness resources.

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