This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Trial Manager II based in Brazil.
As a Clinical Trial Manager II, you will play a critical role in overseeing clinical trial operations and ensuring successful study delivery from site activation through closeout. This position combines strategic oversight, risk management, and operational leadership to support patient safety, regulatory compliance, and high-quality clinical outcomes. You will collaborate with multidisciplinary teams, clinical sites, and stakeholders to ensure studies progress according to timelines, budgets, and quality standards. This opportunity is ideal for an experienced clinical research professional who enjoys solving complex challenges, leading teams, and contributing to the development of therapies that improve patients’ lives worldwide. You will work in a global, collaborative environment where expertise, innovation, and operational excellence are highly valued.
Accountabilities
- Oversee clinical trial management activities, including site management, clinical monitoring, and central monitoring deliverables while ensuring patient safety, protocol compliance, GCP standards, regulatory requirements, and data integrity.
- Manage site interactions from activation through study closeout, including activities related to recruitment, investigator payments, and operational follow-up.
- Identify potential risks affecting study timelines, quality, budget, or execution and develop effective mitigation strategies using clinical experience, operational data, and performance metrics.
- Review study protocols, scopes of work, budgets, and contractual requirements to ensure clinical teams understand project expectations and deliverables.
- Lead and participate in key study meetings, providing operational insights, progress updates, and recommendations to project teams and stakeholders.
- Serve as an escalation point for site-related challenges, supporting communication with investigators and resolving complex operational issues.
- Collaborate with cross-functional teams including data management, study startup, patient recruitment, pharmacovigilance, and quality assurance to achieve study milestones.
- Develop, maintain, and improve clinical study tools, templates, monitoring plans, dashboards, and operational tracking systems.
- Ensure clinical teams receive appropriate training on protocols, study procedures, systems, documentation requirements, and timelines.
- Monitor the quality and compliance of clinical documentation, including monitoring reports, site communications, and trial management records.
- Oversee CRA and central monitoring activities, supporting resource allocation, performance management, corrective actions, and delivery against study objectives.
- Support inspection readiness activities and ensure compliance with internal procedures, sponsor requirements, ICH-GCP guidelines, and applicable regulations.
Requirements
- Bachelor’s degree, nursing degree (RN), or equivalent combination of education, training, and professional experience in clinical research or a related field.
- Proven experience managing clinical trials, including site management, clinical monitoring, or central monitoring activities.
- Demonstrated ability to lead teams and coordinate multidisciplinary stakeholders toward achieving project milestones.
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements.
- Experience working in international clinical research environments with global teams and stakeholders.
- Understanding of risk-based monitoring approaches and clinical trial risk management principles.
- Experience managing clinical trial budgets, operational timelines, and study delivery requirements.
- Strong analytical and problem-solving skills with the ability to identify issues, evaluate risks, and implement effective solutions.
- Excellent communication, presentation, and interpersonal skills when working with project teams, sponsors, investigators, and internal stakeholders.
- Strong conflict resolution abilities and the confidence to manage complex operational situations.
- Good computer skills and familiarity with clinical trial management systems and digital research tools.
- Ability to travel occasionally, approximately 20%, depending on study requirements.
Benefits
- Fully remote full-time position based in Brazil.
- Opportunity to contribute to clinical research programs that support the development of important therapies.
- Collaboration with international teams and experienced professionals across the life sciences industry.
- Career development opportunities through training, mentorship, and exposure to diverse clinical programs.
- Supportive and inclusive work environment focused on professional growth and collaboration.
- Opportunity to work with innovative technologies, data-driven solutions, and global clinical research practices.
- Access to comprehensive resources designed to support long-term career progression.
- Dynamic environment with opportunities to expand expertise across therapeutic areas and clinical operations.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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