Clinical Trial Manager II, Regulatory Experience

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

📋 Description

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

• Manage site interactions from activation to closeout, including patient recruitment and payments to investigators.

• Identify critical data, process risks, risks associated with protocol execution, and develop risk mitigation strategies.

• Review the study scope, budget, and protocol details while communicating contractual obligations to the clinical project team.

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

• Suggest and implement risk mitigation strategies.

• Participate in and present during key meetings, such as Kick Off Meetings.

• Act as a point of escalation for communications with investigator sites and engage with principal investigators and site personnel.

• Coordinate handoffs of delivery with Study Start Up, Patient Recruitment, and Data Management teams.

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

• Ensure the configuration and availability of CTMS, dashboards, and other systems, including user acceptance testing and access/audit trail reviews.

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

• Supervise CRA and Central Monitor resource allocation, site assignments, and the conduct of study teams.

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

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

• Ensure compliance with monitoring strategies, CMP/SMP, and risk management plans.

• Review monitoring documentation to ensure that revisions, approvals, and deliverables align with company and sponsor specifications.

• Interact with clients and functional departments to provide status updates on deliverables and risks.

• Support inspection readiness for the scope of clinical trial management.

• Oversee CRAs and Central Monitors, evaluate compliance and emerging risks, and assist in implementing corrective action plans.

• Support activities to meet data cut and lock deadlines.

• Provide performance feedback on staff to line managers.

• May be assigned to larger and 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 in achieving project milestones.

• Experience working in an international context.

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

• Preferred experience with risk-based monitoring approaches.

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

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

• Proficient computer skills.

• Excellent communication, presentation, and interpersonal skills with project teams and site personnel.

• Strong conflict resolution abilities.

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

• Critical thinking skills to identify causes and appropriate solutions.

• Moderate travel may be required, approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations provided when appropriate.