Clinical Trial Manager

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.