Clinical Trial Manager – FSP

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

📋 Description

• Oversee clinical operational and quality elements of assigned low- to moderate-complexity studies in accordance with ICH GCP standards.

• Take on Clinical Study Manager duties for smaller or less complex projects when necessary.

• Create clinical tools such as Monitoring Plans and Monitoring Guidelines aligned with the Data Quality Plan.

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

• Engage in the design of CRFs, CRF guidelines, informed consent templates, and other documents specific to protocols.

• Work alongside project managers to prepare, organize, and present information during client meetings, including bid defense and hand-off sessions.

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

• Lead team meetings and communicate consistently to maintain timelines, resources, interactions, and quality.

• Implement and provide training on standardized clinical monitoring procedures.

• Ensure the timely archiving of documents and study materials.

• Deliver final clinical outcomes within contractual timelines by monitoring activity timelines and metrics, providing status updates, reviewing projects, implementing recovery strategies, assessing monitoring visit reports, and managing CRF collection and query resolution.

• Monitor or co-monitor clinical trials to evaluate performance and fulfill contractual obligations.

• Conduct Accompanied Field Visits and manage project finances in smaller regions as necessary.

• Communicate with study sites regarding protocols, patient participation, case report forms, and related inquiries.

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

• Guarantee that essential document quality meets Regulatory Compliance Review standards.

• Review and address questions from ethics committees.

• Provide insights for clinical activity forecasts.

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

⛳️ Requirements

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

• 5+ years of relevant experience providing the necessary knowledge, skills, and abilities.

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

• Skills in leadership, mentoring, and training.

• Strong planning and organizational abilities.

• Interpersonal and problem-solving skills in a multicultural matrix organization.

• Capability to work effectively in dynamic environments with complex or ambiguous situations.

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

• Proficient judgment and decision-making skills.

• Effective oral and written communication abilities, including proficiency in English.

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

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

• Strong attention to detail.

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

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

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

🏝️ Benefits

• Fully remote work arrangement.

• Global team environment.

• Opportunities for collaboration and professional development.

• A workplace centered on passion, innovation, and scientific excellence.