Clinical Trial Manager – FSP

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

📋 Description

• Oversee the clinical operational and quality components of assigned low- to moderate-complexity studies while adhering to ICH GCP standards.

• Create clinical tools and assist in the formulation of Data Quality Plans and Master Action Plans.

• Establish, organize, maintain, and archive pertinent sections of the Trial Master File and study documentation.

• Engage in the design of CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents.

• Collaborate with project managers during client meetings, bid defenses, and transition meetings.

• Coordinate clinical teams and departments, lead team meetings, and oversee timelines, resources, interactions, and quality assurance.

• Execute and train teams on standardized clinical monitoring procedures.

• Prepare and track clinical timelines and metrics, deliver project status updates, and implement corrective actions as necessary.

• Review monitoring visit reports, oversee CRF collection and query resolution, and monitor or co-monitor clinical trials.

• Conduct Accompanied Field Visits and manage project finances in smaller regions when applicable.

• Communicate with study sites regarding protocols, patient involvement, case report forms, and other study-related matters.

• Coordinate study start-up activities along with ethics committee and regulatory submissions when necessary.

• Review and address questions from ethics committees.

• Contribute to forecasts of clinical activities and manage clinical resources, assignments, delegations, and additional resource requirements.

⛳️ Requirements

• Bachelor's degree or an equivalent relevant academic or vocational qualification.

• More than 5 years of relevant experience.

• Equivalence may include appropriate education, training, and/or directly related experience.

• Skills in leadership, mentoring, training, motivation, and team integration.

• Strong planning and organizational abilities.

• Interpersonal and problem-solving capabilities in a multicultural matrix environment.

• Knowledge of clinical monitoring practices, processes, and requirements.

• Proficient oral and written communication skills, with a strong command of the English language.

• Ability to assess workload in relation to project budgets and adjust resources accordingly.

• Financial knowledge and expertise in budgeting, forecasting, and fiscal management.

• Keen attention to detail.

• Understanding of relevant regulations, including ICH/GCP and FDA guidelines.

• Proficiency in computer applications such as Outlook, Excel, Word, and similar tools.

• Capability to work in dynamic environments with complex and ambiguous situations.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Regular domestic and international travel.