This position supports sponsor-dedicated clinical trials in Brazil as a Clinical Trial Manager II or Senior Clinical Trial Manager, operating from a home-based location. The role involves managing site activities from activation through closeout, ensuring adherence to protocols, GCP, and regulatory standards, overseeing monitoring strategies, identifying risks, and driving trial execution with a focus on data integrity, patient safety, and compliance.
Responsibilities
- Oversees site management, clinical monitoring, and central monitoring activities, emphasizing patient safety, protocol and regulatory compliance, and data accuracy.
- Manages site interactions after activation through to closeout, including recruitment support, investigator payments, and related tasks.
- Identifies critical data elements, processes, and protocol execution risks, contributing to the Risk Assessment and Categorization Tool (RACT) and associated risk mitigation strategies.
- Reviews study scope, budget, and protocol details to ensure the clinical team understands contractual obligations and project parameters.
- Uses clinical experience and operational metrics to detect risks to trial deliverables and timelines.
- Escalates project risks related to timelines, quality, budget, or out-of-scope requests to the project manager.
- Applies strategic thinking and problem-solving to develop and implement risk mitigation plans.
- Participates in and presents at key study meetings, including kick-off sessions.
- Acts as a point of escalation for communication with investigator sites and may engage directly with principal investigators or site staff via phone or in person.
- May accompany CRAs on site visits for observation or to resolve conflicts.
- Collaborates with functional leads in Study Start Up, Patient Recruitment, and Data Management to coordinate handoffs and meet key milestones such as site activation, enrollment goals, and database lock.
- Reviews and provides input on functional plans like Data Management and Communication Plans as they relate to clinical operations.
- Develops and maintains clinical study tools and templates, including the Clinical Monitoring Plan.
- Ensures CTMS, dashboards, and other systems are configured and available for team use, including overseeing user acceptance testing when needed.
- Conducts or ensures access and audit trail reviews are performed as required.
- Coordinates initial and ongoing training for the study team on protocol specifics, CRF completion, dashboards, sponsor SOPs, clinical plans, data plans, and timelines.
- Oversees CRA and central monitor resourcing, site assignments, team conduct, and identifies risks to delivery or quality.
- Ensures high-quality monitoring and site management outputs and maintains visibility into progress using approved systems and tracking tools.
- Reviews project dashboards and clinical systems—including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards—to monitor site and patient activity, team performance, and data updates reflecting timely execution.
- Understands the study's monitoring strategy and may contribute to developing the risk assessment plan.
- Holds assigned team members accountable for understanding and adhering to the monitoring strategy, Clinical Monitoring Plan, and risk mitigation plans.
- Reviews quality and content of monitoring documentation—including site calls, visit reports, letters, central monitoring reports, and correspondence—to ensure accurate representation of site activities and identification of compliance, safety, or data risks.
- Documents requested revisions and approvals within the CTMS.
- Ensures all deliverables meet company and sponsor requirements, including adherence to deadlines.
- Communicates with clients and other departments regarding monitoring and site management activities and outputs.
Requirements
- Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
- Proven ability to lead and align teams to achieve project milestones.
- Experience working effectively in an international environment.
- Demonstrated expertise in clinical or central site monitoring and site management.
- Understanding of clinical trial financial principles and budget management.
- Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
- Proficient in computer applications and digital tools.
- Strong skills in conflict resolution.
- Proven ability to apply problem-solving techniques to complex issues and use risk management to identify and mitigate threats to clinical trial success.
- Demonstrates critical thinking to identify root causes and determine appropriate solutions.
Nice to Have
- Experience with risk-based monitoring approaches is preferred.
Tech Stack
CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards
Benefits
- Commitment to employee development through career growth and advancement opportunities.
- Supportive and engaged management team.
- Access to technical and therapeutic area training.
- Peer recognition and comprehensive rewards program.
- Dedicated to fostering an inclusive culture where individuals can be authentic.
- Focused on delivering impact—empowering employees to contribute meaningfully to life-changing solutions.
- Opportunity to collaborate with innovators across drug development and commercialization.
Work Arrangement
local-country — Brazil — Home Based
Team
Team of CTMs managing a portfolio of projects; operates within a Functional Service Provider or Full-Service model; collaborates with Study Start Up, Patient Recruitment, Data Management, medical monitoring, pharmacovigilance, Quality Assurance, and project management; reports to project manager and provides performance feedback to line managers.
- Committed to employee development and growth.
- Management is supportive and actively engaged.
