Clinical Trial Manager II

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

📋 Description

• Offer oversight for site management, clinical monitoring, and central monitoring deliverables with an emphasis on patient safety, adherence to protocols/GCP/regulatory compliance, and ensuring data integrity.

• Manage site interactions from activation until closeout, which includes overseeing recruitment and investigator payments.

• Identify risks associated with clinical trials and formulate strategies for risk mitigation.

• Assess study scope, budget, protocol details, and contractual obligations.

• Track operational data, metrics, reports, timelines, quality, and budget-related risks.

• Engage in and present at critical meetings, such as Kick Off Meetings.

• Act as a point of escalation for communications from investigator sites and interact with principal investigators and site staff.

• Facilitate transitions with Study Start Up, Patient Recruitment, and Data Management teams.

• Create and sustain clinical study tools and templates, including Clinical Monitoring Plans.

• Ensure the configuration and availability of CTMS, dashboards, and other systems, including conducting user acceptance testing.

• Organize training for study teams on protocols, CRFs, dashboards, SOPs, plans, data, and timelines.

• Supervise CRA and Central Monitor resource allocation, site assignments, conduct, and associated delivery risks.

• Review monitoring documentation and guarantee timely submission in accordance with company and sponsor standards.

• Deliver updates on clinical deliverables and risk status to clients, project management, and leadership.

• Assist in inspection readiness and support corrective action plans, data cut, and database lock timelines.

• Provide performance feedback to line managers.

• Coordinate clinical activities across complex trials or portfolios.

• Coach and mentor CTMs regarding clinical delivery, project risks, and the implementation of actions.

⛳️ Requirements

• A 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 toward achieving project milestones.

• Demonstrated experience working in an international setting.

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

• Preferred familiarity with risk-based monitoring.

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

• Knowledge of Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills.

• Strong skills in conflict resolution.

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

• Critical thinking skills to identify causes and formulate appropriate solutions.

• Moderate travel may be necessary, approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive rewards program.

• A culture of inclusivity.

• Reasonable accommodations when appropriate.