Clinical Trial Manager II

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

📋 Description

• Oversee site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, compliance with protocols/GCP/regulations, and data integrity.

• Manage site interactions from the post-activation phase to site closeout, including patient recruitment and investigator payments.

• Identify significant risks related to data, processes, and protocol execution, and implement strategies to mitigate these risks.

• Review the scope of work, budget, and protocol content for studies; ensure that clinical project teams understand their contractual obligations and parameters.

• Identify and escalate risks related to timelines, quality, and budget, including activities that fall outside the agreed scope.

• Participate in and present at essential meetings, such as Kick Off Meetings.

• Act as a point of escalation for communications with investigator site staff and interact with principal investigators and site staff via phone or in person.

• Coordinate the handoff of deliverables with Study Start Up, Patient Recruitment, and Data Management to achieve study milestones.

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

• Ensure that systems such as CTMS, dashboards, and others are configured and accessible, including conducting user acceptance testing and reviewing access/audit trails.

• Organize initial and ongoing training for the study team on protocols, CRFs, dashboards, SOPs, plans, and timelines.

• Oversee the allocation of CRAs and Central Monitors, manage site assignments, and ensure appropriate conduct within the study team.

• Monitor the quality and progress of clinical monitoring, central monitoring, and site management deliverables using approved systems and tracking tools.

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

• Ensure that assigned clinical team members understand and adhere to monitoring strategies, CMP/SMP, and risk management plans.

• Review and ensure the quality and timeliness of monitoring documentation per company and sponsor specifications.

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

• Collaborate with functional departments to support inspection readiness.

• Supervise CRAs and Central Monitors, assess compliance, identify emerging risks, and support corrective action plans.

• Assist in meeting data cut and database lock deadlines.

• Offer performance feedback to line managers.

• May be assigned to larger, more complex trials.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or an equivalent combination of education, training, and experience.

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

• Experience in an international working environment.

• Demonstrated expertise in site management and monitoring, whether clinical or central.

• Preferred experience in risk-based monitoring.

• Understanding of financial principles related to clinical trial management and budget management.

• 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 site personnel.

• Excellent conflict resolution abilities.

• Capability to apply problem-solving techniques to resolve complex issues and utilize a risk management approach to identify and mitigate potential threats to successful clinical research projects.

• Critical thinking skills to determine causes and appropriate solutions when issues arise.

• Moderate travel may be required, approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition.

• Comprehensive total rewards program.

• An inclusive organizational culture.

• Reasonable accommodations for employees or applicants with disabilities when appropriate.