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 in accordance with ICH GCP guidelines.

• Take on Clinical Study Manager duties for smaller or less complex projects as needed.

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

• Guarantee the timely setup, organization, content, quality, and archiving of Trial Master File documents and study materials.

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

• Work with project managers to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.

• Facilitate clinical team meetings while managing timelines, resources, interactions, and quality.

• Implement and provide training on standardized clinical monitoring processes.

• Prepare and track clinical activity timelines and metrics, deliver project status updates, review tracking tools, and execute recovery actions.

• 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 necessary.

• Communicate with study sites about protocol, patient participation, case report forms, and other study-related issues.

• Coordinate study initiation activities and handle ethics committee and regulatory submissions as appropriate.

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

• Contribute to clinical activity forecasts and manage clinical resources, assignments, delegation, and additional resource needs.

⛳️ Requirements

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

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

• Consideration may be given for equivalency through a combination of relevant education, training, and/or directly related experience.

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

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

• Proficiency in the English language.

• Competent computer skills, including Outlook, Excel, and Word.

• Strong skills in leadership, mentoring, training, planning, organization, interpersonal relations, problem-solving, judgment, communication, financial management, budgeting, forecasting, and attention to detail.

• Capability to work effectively in a dynamic environment with complex and ambiguous situations and within multicultural matrix organizations.

• Ability to assess workload in relation to project budget and adjust resources as needed.

• Willingness to travel frequently domestically and internationally and drive to site locations.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and development.

• Exposure to passion, innovation, and scientific excellence.

• Full-time employment.