Senior Clinical Trial Manager, FSP

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

📋 Description

• Oversee the clinical operational and quality components of moderate- to high-complexity studies, ensuring adherence to ICH GCP standards.

• Create clinical tools, monitoring plans, guidelines, data quality plans, master action plans, and sections of the Trial Master File.

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

• Prepare for and deliver presentations at client meetings, including bid defense and hand-off sessions.

• Collaborate with clinical teams and other departments; lead team meetings and establish standardized monitoring processes and training programs.

• Track clinical activity timelines and metrics, provide updates on project status, implement recovery actions, review monitoring visit reports, and manage the collection of CRFs and resolution of queries.

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

• Coordinate start-up activities for studies, including regulatory submissions and follow-up with ethics committees as necessary.

• Contribute to forecasts of clinical activities.

• Manage clinical resources, delegate responsibilities, and assess additional resource needs.

• May take on roles such as regional Lead CTM, Clinical Study Manager, process improvement, program management, project coordination, or limited line-management duties.

⛳️ Requirements

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

• At least 8 years of comparable experience.

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

• Strong skills in leadership, mentoring, training, motivation, and team integration.

• Excellent planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, and risk-management abilities.

• Solid grasp of change-management principles.

• Comprehensive knowledge of clinical monitoring practices, processes, and requirements.

• Proficient oral and written communication skills, including fluency in English.

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

• In-depth understanding of pertinent regulations, including ICH/GCP and FDA guidelines.

• Strong computer skills, including proficiency in Outlook, Excel, Word, and other computerized applications.

• Capability to independently manage clinical-only studies.

• Willingness and ability to frequently travel to site locations, both domestically and internationally.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and development.

• Commitment to scientific excellence.