Job Details

Site Manager Job Description

The Site Manager is responsible for overseeing all aspects of clinic operations, staff leadership, and the successful execution of clinical trials. This role ensures that trials are conducted according to established protocols, procedures, and regulatory standards while maintaining operational excellence, financial 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 processes 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 professional growth across all levels of the clinic.
• Collaborate with other departments (Regulatory, Finance, Business Development, and Quality) to ensure seamless trial execution and operational efficiency.
• Monitor clinic performance metrics, proactively identifying areas for improvement and contributing to the site's financial health and sustainability.

Clinical Trial Management

• Oversee and coordinate the conduct of assigned clinical trials, ensuring full compliance with study protocols and sponsor requirements.
• Participate in investigator and site initiation meetings, and serve as a key point of contact for monitors, sponsors, and CROs.
• Ensure timely and accurate participant screening, informed consent, and study visit execution.
• Monitor and document adverse events, deviations, and other safety concerns in accordance with protocol and GCP standards.
• Dispense and account for investigational products, ensuring dosing accuracy and adherence to study-specific instructions.
• 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 all applicable regulatory and quality standards.
• Identify and report protocol deviations, and ensure timely resolution of monitoring 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 per protocol requirements.
• Ensure data integrity by maintaining accurate and timely documentation in all study systems.
• Support data entry, query resolution, and database lock activities as needed.

Financial Stewardship & Site Development

• Contribute to the site's financial performance by managing clinic resources responsibly and identifying cost-saving opportunities without compromising quality.
• Assist in forecasting staffing, supply, and equipment needs to support ongoing and upcoming studies.
• Collaborate with leadership to review site budgets, monitor performance against goals, and drive sustainable growth.

Community & Team Engagement

• Support recruitment and retention efforts by promoting the clinic's mission and reputation within the local community.
• Participate in outreach and educational events to raise awareness of clinical research opportunities.
• Serve as a role model for professionalism, compassion, and service excellence in all patient and sponsor interactions.

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: Exceptional written and verbal communication skills; able to build trust and rapport with diverse teams.
• Technical Proficiency: Proficient in Microsoft Office Suite and electronic clinical systems (e.g., EDC, CTMS).
• Regulatory Knowledge: Working knowledge of ICH-GCP, FDA, and other applicable clinical research regulations.
• Confidentiality: Demonstrated ability to handle sensitive patient and study information with discretion and professionalism.

Summary

This position plays a vital role in ensuring the integrity, accountability, and operational success of the clinic. The Site Manager leads by example, fostering collaboration, maintaining regulatory compliance, and driving both the scientific and financial success of the site while ensuring the highest standards of patient care and ethical conduct.