Clinical Trial Manager II

This is a fully remote position, open to applicants in Brazil, +4 more countries.

📋 Description

• Provide oversight for site management, clinical monitoring, and central monitoring deliverables, emphasizing patient safety, protocol/GCP/regulatory compliance, and data integrity.

• Manage site interactions from activation to closeout, which includes patient recruitment and investigator compensation.

• Identify significant data, process, and protocol-execution risks, and formulate risk mitigation strategies.

• Review the study's scope of work, budget, and protocol content; ensure that clinical project teams comprehend contractual obligations and parameters.

• Recognize and escalate risks that impact timelines, quality, budget, or the contracted scope.

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

• Act as an escalation point for investigator site personnel and engage with principal investigators and other site staff through phone or in-person communication.

• Collaborate with Study Start Up, Patient Recruitment, Data Management, and other functional leaders to achieve study milestones.

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

• Ensure that CTMS, dashboards, and other systems are properly configured and accessible, including supervising UAT and access/audit trail reviews.

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

• Supervise CRA and Central Monitor resources, site assignments, and team conduct.

• Ensure the quality and visibility of clinical monitoring, central monitoring, and site management deliverables through approved systems and tracking tools.

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

• Engage in the development of study risk assessment plans and ensure that team members adhere to monitoring strategies and risk plans.

• Evaluate the quality and content of monitoring documentation and guarantee timely submission in accordance with company and sponsor specifications.

• Interact with clients, project management, leadership, and functional departments; provide status updates and solutions for protocol execution and site management challenges.

• Assist in ensuring inspection readiness for clinical trial management scopes.

• Oversee CRAs and Central Monitors, evaluate process/training/CMP compliance, identify emerging risks, and support corrective action plans.

• Aid activities to meet data cut and lock deadlines.

• Offer performance feedback to line managers regarding staff strengths and areas for development.

• May be assigned to larger, more intricate 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 in achieving project milestones.

• Demonstrated experience working in an international setting.

• Expertise in site management and monitoring (clinical or central) is essential.

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

• Excellent conflict resolution abilities.

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

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

• Moderate travel may be required, approximately 20%.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Total rewards program.

• An inclusive culture that allows employees to authentically be themselves.

• Reasonable accommodations, as appropriate, under the Americans with Disabilities Act.