Clinical Trials Site Manager

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

2h•Onsite

About The Position

The Clinical Trials Site Manager oversees the day-to-day operations of the PRCCI Clinical Research Center and ensures clinical research activities are effective, efficient, and compliant. The role manages site personnel, budgets and resources; oversees study protocol implementation; and ensures adherence to regulatory requirements and institutional policies. The manager serves as a primary liaison among sponsors, investigators, and site personnel, oversees participant recruitment and enrollment, and promotes data quality, integrity, participant safety, and research quality throughout clinical trials. The position oversees multiple trials across the study lifecycle, from start-up and activation through close-out and post-close-out activities. It also supervises and develops research staff; oversees regulatory documentation, compliance, quality management, and performance reporting; and supports sponsor relationships and study budgets and contracts. The manager leads or contributes to special projects and strategic initiatives as PRCCI’s priorities evolve. The role is based on-site in San Juan, Puerto Rico, and may require travel within Puerto Rico and the United States. Occasional work outside regular business hours may be needed.

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 developing relationships with stakeholders at all levels of an organization.
Thorough knowledge of GCP, ICH guidelines, FDA regulations, IRB requirements, and HIPAA.
Ability to interpret and apply complex regulatory requirements, guidelines, and institutional policies to clinical research operations.
Experience implementing and overseeing industry-sponsored clinical trials within the life sciences sector.
Proficiency with 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 trials, competing priorities, and operational processes while meeting deadlines.
Strong leadership, personnel management, and interpersonal skills, including ability to supervise, mentor, motivate, and develop research staff.
Excellent written and verbal communication skills in Spanish and English.
Ability to establish productive professional relationships and collaborate with internal teams and external partners.
Initiative, sound judgment, problem-solving skills, and ability to work independently and within 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 focusing on participant safety, regulatory compliance, data quality, and study performance.
Willingness and ability to travel within Puerto Rico and the United States as needed.
Flexibility to work outside regular business hours occasionally.
Current GCP training or certification.

Nice To Haves

Healthcare professional background.
Experience managing NIH-sponsored clinical trials.
Experience as a Clinical Research Associate (CRA).
Project management methodology experience.
Professional clinical research certification such as CCRC, CCRP, or equivalent.
Exposure to or knowledge of the pharmaceutical and biotechnology industries, particularly clinical trials.

Responsibilities

Oversee day-to-day operations of multiple clinical trials throughout start-up, activation, close-out, and post-close-out activities.
Ensure trials comply with approved protocols, applicable regulations, institutional policies, and established procedures.
Develop, implement, and maintain standard operating procedures, work instructions, and operational documents.
Oversee site resources, facilities, equipment, and operational processes.
Identify operational challenges, implement process improvements, and promote best practices.
Supervise, mentor, evaluate, and support the training and professional development of clinical research coordinators, research nurses, and other site personnel.
Monitor staff performance and workload, allocate resources, and hold regular meetings with direct reports.
Oversee regulatory submissions, approvals, renewals, notifications, regulatory files, essential study documentation, and personnel records.
Maintain accurate documentation in CTMS, SharePoint, and other designated electronic systems.
Monitor regulatory developments and communicate relevant changes to site personnel.
Conduct internal compliance reviews and inspections, develop corrective and preventive action plans, and coordinate preparation for sponsor audits, regulatory inspections, and monitoring visits.
Oversee participant recruitment, screening, enrollment, and retention strategies and monitor related metrics.
Ensure informed consent, eligibility assessments, and study procedures follow approved protocols and applicable requirements; protect participant safety, rights, welfare, and confidentiality.
Serve as a primary contact for sponsors, CROs, principal investigators, regulatory representatives, and other stakeholders; coordinate monitoring visits, site assessments, and study requests.
Facilitate communication among sponsors, investigators, and site personnel 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 accurate, complete, consistent, and timely data entry; monitor data quality, queries, source documentation, and study-specific data requirements.
Ensure adverse events, serious adverse events, protocol deviations, and other reportable events are documented, escalated, and reported on time.
Monitor protocol adherence and quality standards and address deficiencies, noncompliance, audit findings, and recurring issues through corrective and preventive actions.
Develop, monitor, and report KPIs and operational metrics related to study performance, enrollment, data quality, compliance, and productivity.
Prepare periodic reports and performance summaries, analyze trends and risks, recommend corrective actions, and present updates to leadership and stakeholders.
Lead or manage special projects and strategic initiatives, collaborating with internal teams and external partners to improve operations, quality, workflows, and organizational processes.
Adapt to evolving organizational priorities and contribute to initiatives advancing PRCCI’s mission and strategic goals.
Travel within Puerto Rico and the United States as needed for conferences, meetings, industry events, and site or client visits.
Occasionally work outside regular business hours for organizational or sponsor meetings, time-sensitive needs, or high-priority projects.