Clinical Trial Manager – FSP

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

📋 Description

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

• Take on the responsibilities of Clinical Study Manager for smaller or less complex projects as necessary.

• Create clinical tools, monitoring plans, and guidelines, while contributing to data quality and master action plans.

• Establish, organize, maintain, and archive sections of the Trial Master File and associated study materials.

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

• Partner with project managers to prepare for and deliver presentations at client, bid defense, and hand-off meetings.

• Work collaboratively with clinical teams and other departments to achieve project milestones.

• Facilitate team meetings and oversee timelines, resources, interactions, and quality standards.

• Implement and provide training on standardized clinical monitoring processes.

• Prepare and oversee clinical timelines and metrics; deliver status updates and execute recovery actions as needed.

• Review monitoring visit reports while managing CRF collection and query resolution.

• Monitor or co-monitor clinical trials and conduct Accompanied Field Visits when necessary.

• Liaise with study sites regarding protocols, patient involvement, CRF completion, and related matters.

• Manage study start-up activities, including ethics committee and regulatory submissions.

• Evaluate questions from ethics committees and ensure the quality of essential documents.

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

• Ensure that all final clinical deliverables align with contractual time, quality, and cost expectations while maintaining profitability.

⛳️ Requirements

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

• A minimum of 5 years of comparable experience.

• A combination of relevant education, training, and/or directly related experience may be accepted as an equivalency.

• Demonstrated leadership, mentoring, training, and team motivation abilities.

• Strong planning and organizational capabilities.

• Excellent interpersonal and problem-solving skills within a multicultural matrix organization.

• Capacity to work efficiently in dynamic environments with complex or uncertain situations.

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

• Strong judgment and decision-making skills.

• Proficient oral and written communication skills, including a good command of the English language.

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

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

• Keen attention to detail.

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

• Proficiency in computer applications like Outlook, Excel, Word, and similar software.

• Willingness to travel frequently both domestically and internationally.

🏝️ Benefits

• Opportunity to work fully remotely.

• Access to a global team environment.

• Opportunities for collaboration and professional development.

• A work environment focused on scientific excellence.