Site Manager, Excellence and Quality
The Site Manager, Excellence and Quality is responsible for ensuring the highest standards of quality, compliance, and operational excellence across all clinical research activities. This role ensures adherence to regulatory requirements, sponsor expectations, Good Clinical Practice (GCP), and internal Standard Operating Procedures (SOPs), while fostering a culture of continuous improvement and accountability.
The Site Manager serves as a strategic partner to investigators, study coordinators, regulatory personnel, and executive leadership to promote participant safety, data integrity, protocol compliance, and research quality. This position provides oversight of study execution, quality management initiatives, staff support, and process improvement efforts to ensure successful clinical trial conduct.
Essential Duties and ResponsibilitiesGeneral Administrative Responsibilities
- Provide leadership and operational oversight to ensure studies are conducted efficiently and in accordance with SOPs, federal regulations, sponsor requirements, and study protocols.
- Collaborate with Executive Operations and Directors to develop and implement policies and procedures that improve day-to-day clinical trial operations.
- Partner with leadership to develop long-term operational strategies that support organizational growth, business development activities, feasibility assessments, and sponsor qualification visits.
- Maintain strict confidentiality of participant, sponsor, and organizational information.
- Support organizational initiatives that promote operational excellence and quality improvement.
General Quality and Compliance Responsibilities
- Serve as a subject matter resource for staff regarding regulatory requirements, GCP, SOPs, protocol compliance, and quality expectations.
- Monitor and track quality metrics and performance indicators to identify trends and proactively address areas requiring improvement.
- Conduct routine internal audits of:
- Study conduct
- Source documentation
- Regulatory files
- Informed consent processes
- Investigational product accountability
- Data quality and integrity
- Lead quality improvement investigations, corrective action plans, and root cause analyses related to protocol deviations, compliance concerns, and process deficiencies.
- Assist with preparation for sponsor audits, regulatory inspections, accreditation reviews, and quality assurance assessments.
- Foster a culture of accountability, continuous learning, and operational excellence throughout the organization.
- Promote a participant-centered approach while maintaining protocol compliance and study rigor.
- Identify recurring errors and performance trends and collaborate with leadership to implement targeted training and process improvements.
Protocol Preparation and Study Start-Up
- Review and maintain a thorough understanding of study protocols, Investigator Brochures, package inserts, laboratory manuals, pharmacy manuals, and other study-specific materials.
- Identify potential operational risks and develop mitigation strategies prior to study initiation.
- Participate in Site Initiation Visits (SIVs), investigator meetings, sponsor trainings, and other required study-related meetings.
- Oversee study start-up activities for new protocols, ensuring successful implementation and operational readiness.
- Utilize and oversee completion of Study Start-Up Checklists to ensure proactive preparation before participant screening begins.
- Ensure proper implementation and utilization of study materials, including:
- Informed Consent Forms (ICFs)
- Enrollment logs
- Drug accountability records
- Essential study documents
- Collaborate with the Manager of Data and Clinical Research (MDCR) to create, quality-check, print, and implement source documentation and study tools.
- Assist with implementation of new study systems, workflows, and operational processes.
Conduct of Research
- Serve as an accessible resource to study teams by providing guidance on protocol requirements, study procedures, documentation standards, and regulatory compliance.
- Assist with day-to-day study operations as needed to ensure continuity of research activities.
- Oversee participant screening processes to ensure eligibility criteria are met through review of Eligibility Worksheets and completion or delegation of Independent Eligibility Verification.
- Ensure timely completion and reporting of:
- Protocol deviations
- Adverse events (AEs)
- Serious adverse events (SAEs)
- Electronic Data Capture (EDC) entry
- Sponsor requests
- Investigator signatures
- Other time-sensitive study requirements
- Maintain effective communication with investigators, directors, sponsor representatives, and study personnel throughout the conduct of each clinical trial.
- Work closely with the MDCR to manage daily operational activities, protocol implementation, issue resolution, and study oversight.
- Monitor study performance and compliance trends and communicate findings to leadership to support ongoing quality improvement efforts.
- Provide limited operational coverage for staffing needs as necessary to support study continuity and participant care.
QualificationsEducation and Experience
- Bachelor's degree in a health science, life science, nursing, or related field preferred.
- Minimum of 3–5 years of clinical research experience required.
- Previous experience in clinical research site management, quality assurance, compliance oversight, or leadership preferred.
- Strong knowledge of ICH-GCP guidelines, FDA regulations, and human subject protection requirements.
Knowledge, Skills, and Abilities
- Comprehensive understanding of clinical trial operations and regulatory requirements.
- Strong leadership, organizational, and problem-solving skills.
- Ability to analyze data and quality metrics to identify trends and implement corrective actions.
- Excellent written and verbal communication skills.
- Strong attention to detail and commitment to quality.
- Ability to effectively manage multiple priorities in a fast-paced environment.
- Proficiency with electronic data capture systems, CTMS platforms, and Microsoft Office applications.
Physical Requirements
- Ability to sit, stand, walk, and use a computer for extended periods.
- Ability to occasionally lift up to 25 pounds.
- Ability to perform duties within a clinical research environment.
Pay: From $85,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Health savings account
- Paid time off
- Professional development assistance
- Retirement plan
- Vision insurance
Education:
Experience:
- working in Clinical Trials: 3 years (Required)
License/Certification:
- Good Clinical Practice Certification (Required)
Work Location: In person
