Clinical Trial Manager, FSP

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

📋 Description

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

• Create clinical tools, monitoring strategies, guidelines, and plans for data quality.

• Assist in the development of Master Action Plans and maintain pertinent sections of the Trial Master File.

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

• Work alongside project managers to prepare for and conduct client meetings, including bid defense and transition meetings.

• Collaborate with clinical teams and various departments to achieve project objectives.

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

• Execute and provide training on standardized clinical monitoring procedures.

• Organize the archiving of study documents and materials.

• Develop and oversee clinical activity timelines and performance metrics.

• Offer updates on project status, review tracking tools, implement corrective actions, assess monitoring visit reports, and oversee CRF collection and query resolution.

• Monitor or co-monitor clinical trials and evaluate performance according to contractual commitments.

• Conduct Accompanied Field Visits and manage financial aspects of projects in smaller regions.

• Communicate with study sites regarding protocols, patient involvement, case report forms, and study-related concerns.

• Coordinate study initiation activities and handle submissions to ethics committees and regulatory bodies.

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

• Contribute to forecasts related to clinical activities.

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

⛳️ Requirements

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

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

• A combination of suitable education, training, and/or directly related experience may be deemed equivalent.

• Strong leadership, mentoring, training, motivational, and team-integration abilities.

• Excellent planning and organizational capabilities.

• Robust interpersonal and problem-solving skills.

• Ability to operate effectively in dynamic environments with complex and ambiguous situations.

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

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

• Capacity to assess workload against project budgets and make necessary resource adjustments.

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

• Exceptional attention to detail.

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

• Proficient computer skills, including knowledge of Outlook, Excel, Word, and other computerized applications.

• Willingness to travel frequently, both domestically and internationally.

• Regularly required to drive to site locations.

🏝️ Benefits

• A global team environment.

• Opportunities for collaboration and professional development.

• Exposure to passion, innovation, and scientific excellence.

• Standard Monday–Friday work schedule.