Senior Clinical Trial Manager, FSP

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

📋 Description

• Oversee all operational and quality aspects of assigned moderate- to high-complexity studies while ensuring compliance with ICH GCP standards.

• Take on roles such as regional Lead CTM, Clinical Study Manager, process improvement, complex program management, or project coordination as needed.

• Create clinical tools like Monitoring Plans and Monitoring Guidelines in conjunction with the Data Quality Plan.

• Contribute to the Master Action Plan, ensuring the timely setup, organization, content, and quality of Trial Master File sections.

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

• Collaborate with the project manager to prepare, organize, and present during client meetings, including bid defense and hand-off sessions.

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

• Implement and provide training on standardized clinical monitoring processes.

• Track clinical activity timelines and metrics, offer status updates, review projects, and execute recovery actions as necessary.

• Review monitoring visit reports, oversee CRF collection and query resolution, and evaluate trial performance against contractual obligations.

• Conduct Accompanied Field Visits and manage project financials as required.

• Liaise with study sites regarding protocol, patient participation, case report forms, and study-related concerns.

• Coordinate study start-up activities, ensuring the quality of essential documents and timely regulatory submissions.

• Review and address queries from ethics committees.

• Provide insights into clinical activity forecasts.

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

• Potentially take on limited line management responsibilities for assigned GPHS projects in North America.

⛳️ Requirements

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

• A minimum of 8 years of prior experience providing the knowledge, skills, and abilities necessary for the role.

• Equivalent experience may be considered through a combination of appropriate education, training, and/or directly related experience.

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

• Excellent planning, organizational, prioritization, interpersonal, and problem-solving skills.

• Solid grasp of change management principles.

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

• Strong judgment, decision-making, risk management, and escalation skills.

• Effective oral and written communication skills, with proficiency in the English language.

• Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management.

• Exceptional attention to detail.

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

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

• Ability to independently manage clinical-only studies.

• Capacity to work in a multicultural matrix organization.

• Willingness to travel frequently, both domestically and internationally.

• Exposure to an office environment with electrical equipment.

🏝️ Benefits

• Fully remote work arrangement.

• Opportunities for collaboration and professional development.

• Global team environment.

• Frequent opportunities for domestic and international travel.