Site Manager

Job Summary

Manage a clinical research site(s) in a designated market. They are responsible for ensuring the smooth and effective operation of clinical trials to meet sponsor and NCR goals, maintaining regulatory compliance, and optimizing performance across their site(s), They are ultimately accountable for the performance of the site, ensuring that enrollment goals and quality standards are met or exceeded, on time and on or under budget. The ideal candidate will have strong experience in clinical research-and the ability to lead their team to operational excellence.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or related field (required). A Master's degree or higher in a relevant discipline is a plus. Minimum of 3 years of experience in a clinical research site. An equivalent combination of education, experience, and/or performance may be considered.
• Deep understanding of clinical trial operations, regulations, and best practices.
• Excellent organizational, problem-solving, and decision-making skills.
• Exceptional communication and interpersonal skills to effectively collaborate with diverse stakeholders.
• Ability to lead a team in a fast-paced environment, prioritize tasks, and meet goals and deadlines.
• Familiarity with electronic medical records, electronic data capture systems and other clinical trial software platforms.
• Aptitude for budget management and financial planning for clinical research studies.
• Knowledge of relevant disease areas, therapeutic indications, and medical terminology.

Physical Demands

Requires extensive mobility: walking, standing, bending, stooping, kneeling, crouching, or crawling. Ability to sit for long periods of time. Pushing, pulling, and lifting of equipment. Requires mental alertness and accuracy for decision making. Requires ability to speak and hear. Repetitive motion required for extensive use of computers. Good visual acuity. Ability to lift up to 25 pounds. Requires regular travel to sites within the region, with occasional travel to corporate office.

Mental Demands

• Requires English language skills for constant high-level written and interpersonal communications.
• Ability to work well with physicians, team members, representatives from other healthcare organizations seeking credentialing information, and others.

Environmental Exposure

Possible exposure to blood borne pathogens. Possible exposure to chemical and electrical hazards.

NextStage Values and Culture

As a team member of NextStage, you are expected to demonstrate behaviors that reflect our Values and Culture and act in ways that promote the best interest of our patients, physicians, and customers entrusted to our care.

Position Responsibilities

• Site Management: Directly manage a clinical research site(s) within a market, ensuring the site meets performance and financial targets. Monitor the progress of clinical trials, ensuring compliance with study protocols, GCP (Good Clinical Practice), and regulatory guidelines. Work with Region Managers to evaluate and optimize performance, address challenges, and ensure that all study-related activities are executed efficiently and per SOPs.
• Staff Leadership & Development: Lead and mentor CRCs and other clinical staff at the site, providing support and guidance for professional development and optimal performance. Recruit, train, and retain site personnel to build a strong, high-performing team. Foster a culture of collaboration, accountability, and continuous improvement within designated clinical research site. Surface and resolve challenges and share best practices in a timely manner.
• Quality Assurance & Compliance: Ensure adherence to regulatory requirements, company policies, and SOPs (Standard Operating Procedures) at the sites. Review and assess site performance metrics, implement corrective actions when necessary, and ensure continuous improvement in data quality and patient safety. Address and resolve any issues related to protocol deviations, non-compliance, or site-specific challenges.
• Financial & Budget Management: Work with Region Manager and the finance team to ensure that site budgets adhered to and identify opportunities for cost-savings without compromising quality. Monitor site performance against budgeted targets, and address any discrepancies or financial concerns in a timely manner.
• Client & Sponsor Relations: Act as an escalation point for BD or sponsors if there are issues identified at your site.
• Healthcare Partner Relations: Ensure strong and collaborative relationships between NextStage Clinical team members and Principal Investigators, Sub-Investigators, other doctors, and clinical teams within the practices we work with.
• Reporting & Documentation: Utilize the standard site visit checklist to ensure strong site performance, trial progress, and recruitment efforts, and to proactively identify any potential risks or challenges.