Position Overview
The Site Manager is responsible for overseeing all aspects of clinic operations, staff leadership, and the successful execution of clinical trials. This role ensures studies are conducted in accordance with established protocols, company procedures, and regulatory standards, while maintaining operational excellence, fiancial health, and a culture of accountability and integrity.
Key Responsibilities
Clinic Operations & Staff Leadership
- Manage the day-to-day operations of the clinic, ensuring all activities align with company standards and regulatory requirements.
- Lead, train, and develop clinical and administrative staff to achieve site goals and uphold company values.
- Foster a culture of accountability, teamwork, and continuous professional growth across the clinic.
- Collaborate with cross-functional departments (Regulatory, Finance, Business Development, and Quality) to support seamless trial execution and operational efficiency.
- Monitor clinic performance metrics, proactively identify areas for improvement, and contribute to the site's financial sustainability.
Clinical Trial Management
- Oversee and coordinate assigned clinical trials, ensuring compliance with study protocols and sponsor requirements.
- Participate in investigator meetings and site initiation visits; serve as a primary point of contact for sponsors, CROs, and monitors.
- Ensure timely and accurate participant screening, informed consent, and study visit execution.
- Monitor, document, and escalate adverse events, protocol deviations, and safety concerns in accordance with GCP and study requirements.
- Oversee investigational product dispensing, accountability, and documentation.
- Maintain accurate and complete study records, including source documentation and case report forms.
Compliance & Quality Assurance
- Uphold the highest standards of ethical conduct, integrity, and patient confidentiality.
- Ensure compliance with company SOPs, study protocols, and applicable regulatory requirements.
- Identify, document, and support resolution of monitoring findings, deviations, and data queries.
- Participate in internal audits, sponsor inspections, and continuous quality improvement initiatives.
Specimen Handling & Data Management
- Oversee specimen collection, processing, storage, and shipment in accordance with protocol specifications.
- Ensure data integrity through accurate, timely documentation across all study systems.
- Support data entry, query resolution, and database lock activities as required.
Financial Stewardship & Site Development
- Contribute to the site's financial performance by responsibly managing clinic resources.
- Assist with forecasting staffing, supply, and equipment needs to support current and upcoming studies.
- Collaborate with leadership to review site budgets, monitor performance against goals, and support sustainable growth.
Community & Team Engagement
- Support patient recruitment and retention by promoting the clinic's mission and reputation within the community.
- Participate in outreach, educational, and recruitment initiatives.
- Serve as a role model for professionalism, compassion, and service excellence in all patient, staff, and sponsor interactions.
Additional Responsibilities
This job description outlines the primary duties of the Clinic Manager; however, additional responsibilities may arise as business needs evolve. These responsibilities are not limited to those listed above and may include supporting additional clinical trial activities, assisting with special projects, providing coverage or leadership support during staffing changes, and addressing emerging operational or compliance needs. Flexibility, adaptability, and a willingness to take on new challenges are essential to the overall success of the clinic and its clinical research programs.
Requirements
Required Skills & Qualifications
- Leadership & Accountability: Proven ability to lead teams with integrity, motivate others, and hold staff accountable to performance and ethical standards.
- Operational Excellence: Strong organizational, time management, and problem-solving skills with a focus on continuous improvement.
- Communication: Excellent written and verbal communication skills with the ability to build trust across diverse teams.
- Technical Proficiency: Proficiency in Microsoft Office and electronic clinical systems (e.g., EDC, CTMS).
- Regulatory Knowledge: Working knowledge of ICH-GCP, FDA regulations, and applicable clinical research standards.
- Confidentiality: Demonstrated ability to manage sensitive patient and study information with professionalism and discretion.
