Clinical Trial Manager – Project Management

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Provide oversight for site management, clinical monitoring, and central monitoring deliverables, prioritizing patient safety, adherence to protocols/GCP/regulatory standards, and data integrity.

• Manage site interactions from activation through to closeout, encompassing recruitment, investigator payments, and related tasks.

• Identify critical risks related to data, processes, and protocol execution, and develop mitigation strategies using the RACT.

• Review the study scope, budget, and protocol content, ensuring that clinical project teams comprehend their contractual obligations.

• Recognize and escalate risks concerning timelines, quality, budget, and contracted scope.

• Participate in and present during key meetings, including Kick-Off Meetings.

• Act as an escalation point for communications with investigator site staff and engage with investigators and site personnel either via phone or in person.

• Collaborate with Study Start-Up, Patient Recruitment, Data Management, and other departments to meet study milestones.

• Develop and maintain clinical study tools and templates, such as Clinical Monitoring Plans.

• Ensure that CTMS, dashboards, and other systems are properly configured and accessible, including conducting user acceptance testing and reviews of access/audit trails.

• Coordinate training for study teams on protocols, CRF completion, dashboards, SOPs, clinical plans, data plans, and timelines.

• Oversee the resourcing of CRAs and Central Monitors, site assignments, and the conduct of the study team.

• Ensure the quality and visibility of clinical monitoring, central monitoring, and site management deliverables.

• Review oversight dashboards and clinical trial systems, including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central monitoring dashboards.

• Monitor compliance with strategies related to monitoring, CMP/SMP, and risk plans.

• Review documentation from site and central monitoring to ensure timely and compliant delivery.

• Provide updates to clients, project management, and leadership on deliverables and risks.

• Assist in inspection readiness, corrective action plans, data cuts, and database lock deadlines.

• Supervise CRAs and Central Monitors, evaluate compliance, and identify emerging risks.

• Offer performance feedback for staff to line managers; may also support larger, more complex trials.

⛳️ Requirements

• Bachelor’s degree or RN in a related field, or a comparable combination of education, training, and experience.

• Proven ability to lead and align teams to achieve project milestones.

• Demonstrated capability to operate effectively in an international environment.

• Established expertise in site management and monitoring (clinical or central).

• Preferred experience in risk-based monitoring.

• Understanding of clinical trial management financial principles and budget oversight.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills.

• Strong communication, presentation, and interpersonal skills with project teams and sites.

• Excellent conflict resolution abilities.

• Capability to apply problem-solving techniques to address complex issues and employ a risk management approach.

• Critical thinking skills to identify causes and devise appropriate solutions to issues.

• Moderate travel may be necessary, approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition.

• Comprehensive total rewards program.

• A culture that promotes authenticity and inclusion, known as Total Self.

• Initiatives focused on diversity, equity, and belonging.