Clinical Trials Site Manager

Puerto Rico Science Technology & Research Trust•San Juan, PR

5d•Onsite

About The Position

The Clinical Trials Site Manager (CSM) oversees the day-to-day operations of the PRCCI Clinical Research Center and ensures clinical research activities are effective, efficient, and compliant. The role combines clinical trial site management with regulatory oversight, including management of site personnel, budgets, resources, study protocols, participant recruitment and enrollment, data quality, and regulatory requirements. The CSM serves as a primary liaison among sponsors, investigators, and site personnel and promotes participant safety and research quality throughout the clinical trial process. The CSM manages multiple clinical trials across their lifecycle, from start-up and activation through close-out and post-close-out activities. The position supervises and develops clinical research staff; oversees regulatory submissions, records, inspections, and compliance; supports recruitment and retention; coordinates stakeholder communications; oversees data quality and quality management; and monitors and reports operational performance. The role also leads special projects and strategic initiatives that support PRCCI’s operational effectiveness, growth, and development. The job description may change as organizational needs and projects evolve. This is a full-time, regular position with a probationary period, based on-site in San Juan, Puerto Rico. The role may require travel within Puerto Rico and the United States, as needed, and occasional work outside regular business hours.

Requirements

Advanced degree in a life sciences discipline; a healthcare professional background is preferred.
At least 3 years of experience managing clinical trials at an industry-sponsored clinical research site.
Experience implementing and overseeing industry-sponsored clinical trials within the life sciences sector.
Experience managing NIH-sponsored clinical trials.
Experience developing relationships with stakeholders at all levels of an organization.
Current Good Clinical Practice (GCP) training or certification.
Thorough knowledge of GCP, ICH guidelines, FDA regulations, IRB requirements, HIPAA, and applicable institutional policies.
Ability to interpret and apply complex regulatory requirements, guidelines, and policies to clinical research operations.
Proficiency with clinical research platforms, including CTMS, EDC systems, and document management systems, and ability to learn and use new software, information systems, emerging technologies, and AI tools.
Strong organizational, analytical, and critical-thinking skills, attention to detail, and commitment to data accuracy, quality, and integrity.
Ability to manage multiple clinical trials, competing priorities, and operational processes while meeting deadlines.
Leadership, personnel management, and interpersonal skills, including ability to supervise, mentor, motivate, and support staff development.
Excellent written and verbal communication skills in Spanish and English, including ability to explain complex regulatory and operational information clearly.
Ability to build productive professional relationships and collaborate with internal teams and external partners.
Initiative, sound judgment, problem-solving skills, and ability to work independently and as part of a multidisciplinary team.
Integrity, accountability, dependability, adaptability, professionalism, and commitment to continuous improvement and operational excellence.
Ability to work effectively in a dynamic, fast-paced clinical research environment while prioritizing participant safety, compliance, data quality, and study performance.
Willingness and ability to travel within Puerto Rico and the United States as needed for conferences, meetings, industry events, and site or client visits.
Flexibility to work outside regular business hours occasionally for meetings, time-sensitive operational needs, or high-priority projects.

Nice To Haves

Experience as a Clinical Research Associate (CRA).
Experience with project management methodologies.
Professional clinical research certification such as CCRC, CCRP, or equivalent.
Exposure to or knowledge of the pharmaceutical or biotechnology industry, specifically clinical trials.
A healthcare professional background.

Responsibilities

Oversee day-to-day operations of multiple clinical trials throughout the study lifecycle, from start-up and activation through close-out and post-close-out activities.
Ensure trials comply with approved protocols, applicable laws and regulations, institutional policies, and established procedures.
Develop, implement, and maintain SOPs, work instructions, and operational documents.
Oversee site resources, facilities, equipment, and operational processes, and implement process improvements and best practices.
Supervise clinical research coordinators, research nurses, and other assigned personnel; provide guidance, mentorship, performance evaluations, training, and professional development support.
Monitor staff performance and workload, allocate resources, set expectations, and hold regular meetings with direct reports.
Oversee compliance with GCP, ICH guidelines, FDA regulations, IRB requirements, and other applicable requirements.
Ensure regulatory submissions, approvals, renewals, notifications, study files, personnel records, training records, licenses, certifications, and delegation records are accurate, current, and timely.
Maintain study documentation in designated systems, including CTMS and SharePoint, and monitor regulatory developments for relevant changes.
Conduct internal compliance reviews and inspections; identify gaps; develop and implement CAPAs; and coordinate preparation for sponsor audits, regulatory inspections, and monitoring visits.
Oversee participant recruitment, screening, enrollment, and retention strategies and metrics; address barriers to achieving enrollment targets.
Ensure participant eligibility assessments, informed consent, and study procedures follow approved protocols and applicable requirements, while protecting participant safety, rights, welfare, and confidentiality.
Address participant concerns and collaborate with investigators and site personnel to resolve issues affecting safety, satisfaction, or retention.
Serve as a primary contact for sponsors, CROs, principal investigators, regulatory representatives, and other stakeholders on site operations and study activities.
Coordinate sponsor monitoring visits, site assessments, and study requests; facilitate communication and collaboration; and provide updates on study status, enrollment, KPIs, milestones, and action items.
Review study contracts and budgets and support negotiations with organizational leadership and internal stakeholders.
Oversee site data management to promote data accuracy, completeness, consistency, and timely entry; monitor data quality, query resolution, source documentation, and study-specific data requirements.
Ensure adverse events, serious adverse events, protocol deviations, and other reportable events are documented, escalated, and reported within required timelines.
Monitor protocol adherence and quality standards, document deficiencies, and implement corrective and preventive actions.
Ensure site facilities and equipment are maintained in appropriate working condition and meet applicable safety, operational, and regulatory requirements.
Develop, monitor, and report KPIs and operational metrics related to study performance, enrollment, data quality, regulatory compliance, and productivity.
Prepare periodic reports, performance summaries, study updates, operational reports, and compliance findings; analyze trends and recommend corrective actions.
Lead and manage special projects and strategic initiatives, coordinating with internal teams and external partners to establish priorities, monitor progress, and achieve objectives.
Identify opportunities to improve research operations, quality, workflows, and organizational processes, and adapt to evolving priorities.