Region Manager

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

📋 Description

• Supervise daily operations across various clinical research sites in the region.

• Ensure that trials are executed in full compliance with Good Clinical Practice (GCP), FDA regulations, ICH standards, and protocol specifications.

• Lead all stages of clinical trial implementation, including site initiation, monitoring, participant recruitment, and study close-out.

• Guarantee consistent, high-quality data collection and prompt patient enrollment at all locations.

• Guide, mentor, and support site-level teams, including Principal Investigators, Clinical Research Coordinators, and additional staff members.

• Foster a cooperative and high-performance workplace culture through coaching, development, and team-building initiatives.

• Actively address site-level challenges and performance concerns.

• Ensure rigorous compliance with study protocols, IRB/ethics board standards, and relevant federal regulations.

• Conduct internal audits of sites and manage corrective actions when necessary.

• Keep accurate and timely documentation, including Informed Consent Forms (ICFs), Adverse Events (AEs), Serious Adverse Events (SAEs), and source documents.

• Oversee site budgets and ensure compliance with financial agreements.

• Assist in contract negotiations and manage invoicing and payment procedures.

• Collaborate with sponsors, CROs, and internal teams to facilitate smooth clinical trial execution.

• Track site performance metrics (e.g., enrollment, retention, data quality) and provide regular updates to leadership.

⛳️ Requirements

• At least 5 years of clinical research experience, including a minimum of 1 year in a leadership position.

• Experience in managing multiple sites is preferred.

• Proven expertise in overseeing various clinical research trials across different therapeutic areas is required.

• Strong knowledge of GCP, FDA regulations, ICH guidelines, and industry best practices is essential.

• A Bachelor’s Degree is preferred, or an equivalent combination of education, training, and experience is acceptable.

🏝️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays.

• 100% Employer paid medical, dental, and vision insurance plan options.

• Health Savings Account and Flexible Spending Accounts.

• Bi-weekly HSA employer contribution.

• Company paid Short-Term Disability and Long-Term Disability.

• 401(k) Retirement Plan, with Company Match.