Clinical Trial Manager

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

📋 Description

• Oversee the clinical operational and quality dimensions of assigned low- to moderate-complexity studies in line with ICH GCP standards.

• Create clinical tools and contribute to Data Quality Plans and Master Action Plans.

• Ensure timely establishment, organization, content accuracy, and quality of Trial Master File sections.

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

• Work collaboratively with project managers during client meetings, bid defenses, and hand-off sessions.

• Partner with clinical teams and departments to uphold timelines, resources, interactions, and quality standards.

• Facilitate team meetings and implement as well as train standardized clinical monitoring processes.

• Archive documents and study materials promptly.

• Prepare and track clinical timelines and metrics, deliver project status updates, and execute recovery actions as needed.

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

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

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

• Coordinate study start-up activities and handle ethics committee and regulatory submissions when relevant.

• Ensure the quality of essential documents and follow up on inquiries from the ethics committee.

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

⛳️ Requirements

• A Bachelor's degree or equivalent and relevant formal academic/vocational qualification.

• Over 5 years of prior experience providing the knowledge, skills, and abilities necessary to perform the role.

• Equivalency may comprise a combination of suitable education, training, and/or directly related experience.

• Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, and decision-making abilities.

• Familiarity with clinical monitoring practices, processes, and requirements.

• Proficient oral and written communication skills, including proficiency in the English language.

• Capability to assess workload against project budget and adjust resources accordingly.

• Financial acumen with knowledge of budgeting, forecasting, and fiscal management.

• Excellent attention to detail.

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

• Proficient computer skills using Outlook, Excel, Word, and similar automated systems.

• Ability to work efficiently in a dynamic environment with complex and ambiguous situations.

• Capacity to operate effectively in a multicultural matrix organization.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and development.

• Exposure to passion, innovation, and scientific excellence.