Clinical Trial Manager

Clinical Trial Manager

This is an opportunity to oversee critical clinical trial activities within a global research environment focused on patient safety, data integrity, and regulatory compliance. You will provide operational leadership across site management, clinical monitoring, central monitoring, and study delivery activities. The role combines clinical expertise, risk management, stakeholder coordination, and strategic problem-solving to keep complex studies on track. You will work closely with CRAs, Central Monitors, project managers, functional leaders, clients, and investigator sites to achieve key milestones. Your experience will help identify emerging risks, implement mitigation strategies, and maintain high-quality execution throughout the study lifecycle. You will also contribute to team development through training, coaching, performance feedback, and support for inspection readiness. The position offers exposure to international clinical research programs and opportunities to contribute to increasingly complex trials and portfolios.

Accountabilities

• Provide oversight of site management, clinical monitoring, and central monitoring activities, with a strong focus on patient safety, protocol compliance, GCP/regulatory requirements, and data integrity.
• Oversee site interactions from activation through closeout, including patient recruitment activities, investigator payments, site communications, and related operational activities.
• Identify critical data, process, protocol execution, and operational risks, and contribute to risk assessment and categorization activities.
• Review study scope of work, budget, protocol requirements, and contractual parameters, ensuring clinical team members understand their responsibilities and delivery expectations.
• Use clinical experience, operational data, metrics, dashboards, and reports to identify risks affecting timelines, quality, budget, or other clinical trial deliverables.
• Escalate risks, scope changes, obstacles, and delivery concerns to project management and leadership while proposing practical mitigation strategies.
• Participate in and present at key study meetings, including Kick Off Meetings and other operational forums.
• Serve as an escalation point for investigator site communications and, when required, interact directly with principal investigators and site staff by phone or in person.
• Coordinate with functions including Study Start Up, Patient Recruitment, Data Management, Medical Monitoring, Pharmacovigilance, and Quality Assurance to support study milestones and effective delivery handoffs.
• Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans, while ensuring relevant clinical systems, dashboards, and tracking tools are appropriately configured and available.
• Oversee user acceptance testing, system access, audit trail reviews, and appropriate use of clinical trial technologies and operational tracking systems.
• Coordinate initial and ongoing study-specific training covering protocol requirements, CRF completion, dashboards, SOPs, clinical plans, data plans, and timelines.
• Oversee CRA and Central Monitor resourcing, site assignments, team conduct, and delivery quality, identifying emerging risks and resource requirements.
• Monitor the quality and progress of clinical deliverables through approved systems and tracking tools, ensuring activities are completed according to study plans and timelines.
• Review clinical trial systems and dashboards, including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central monitoring platforms, to maintain visibility into site, patient, and study activities.
• Ensure assigned clinical team members understand and comply with monitoring strategies, Clinical Monitoring Plans, site management plans, risk plans, SOPs, and applicable regulations.
• Review the quality and completeness of site monitoring documentation, central monitoring reports, site letters, correspondence, and other clinical deliverables, ensuring risks and compliance issues are appropriately documented and addressed.
• Provide regular status updates on clinical deliverables, risks, milestones, and obstacles to clients, project management, and leadership.
• Support corrective and preventive actions at site and study level and contribute to achieving data cut, database lock, and other critical study deadlines.
• Support inspection readiness for clinical trial management activities and demonstrate an understanding of how cross-functional teams contribute to compliant study delivery.
• Provide performance feedback to line managers regarding team members' strengths, development opportunities, and areas requiring additional support.
• Take responsibility for larger or more complex trials when assigned and potentially coordinate clinical activities across teams of Clinical Trial Managers.
• Coach and mentor other Clinical Trial Managers on clinical delivery, risk evaluation, problem-solving, and implementation of appropriate actions.

Requirements:

• Bachelor's degree or RN qualification in a related field , or an equivalent combination of education, training, and professional experience.
• Demonstrated experience and expertise in clinical site management and monitoring , including clinical or central monitoring activities.
• Proven ability to lead, coordinate, and align cross-functional teams toward the achievement of clinical trial milestones.
• Demonstrated experience working effectively within an international clinical research environment .
• Knowledge of Good Clinical Practice (GCP), ICH Guidelines , and other applicable regulatory requirements.
• Preferred experience with risk-based monitoring and the ability to apply risk management principles to clinical trial operations.
• Understanding of clinical trial financial principles, including budget management and contractual considerations .
• Strong problem-solving and critical-thinking skills, with the ability to identify root causes, evaluate potential solutions, and implement appropriate actions.
• Strong conflict-resolution and stakeholder-management skills, with confidence communicating with investigators, site staff, clients, project teams, and senior stakeholders.
• Demonstrated ability to identify potential threats to study delivery and develop effective risk mitigation strategies.
• Strong organizational skills and attention to detail, with the ability to manage multiple operational priorities while maintaining quality and compliance.
• Good computer skills and confidence working with clinical trial management systems, dashboards, tracking tools, and related technologies.
• Strong communication skills, with the ability to provide clear updates, document risks, and collaborate effectively across functions and geographies.
• Ability to provide guidance, coaching, and constructive feedback to clinical team members.
• Willingness and ability to travel moderately, approximately 20% .

Benefits:

• Remote working opportunity based in Mexico .
• Opportunity to work on international clinical research programs and complex clinical trials.
• Exposure to cross-functional teams spanning clinical operations, data management, study start-up, patient recruitment, medical monitoring, pharmacovigilance, and quality assurance.
• Professional development and career progression opportunities within a global clinical research environment.
• Access to technical and therapeutic-area training.
• Supportive and engaged line management.
• Peer recognition and total rewards programs.
• Opportunities to develop leadership, mentoring, risk management, and clinical trial oversight expertise.
• Inclusive and collaborative working environment with colleagues and stakeholders across different countries and cultures.
• Opportunity to contribute to clinical research programs focused on advancing therapies and improving patient outcomes.
• Compensation and additional benefits are provided according to the applicable local employment package.