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 in accordance with ICH GCP regulations.

• Take on Clinical Study Manager duties for smaller and/or less complex projects as needed.

• Create clinical tools such as Monitoring Plans and Monitoring Guidelines, alongside the Data Quality Plan.

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

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

• Work closely with the project manager to prepare, organize, and deliver presentations at client meetings, including bid defense and hand-off meetings.

• Collaborate with clinical teams and other departments to meet project objectives.

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

• Implement and provide training on standardized clinical monitoring processes.

• Ensure timely archiving of documents and study materials.

• Deliver final clinical outputs within agreed timelines by preparing and tracking timelines and metrics, providing status updates, reviewing projects, implementing recovery actions, evaluating monitoring visit reports, and managing CRF collection and query resolution.

• Monitor or co-monitor clinical trials to evaluate performance and ensure contractual obligations are met.

• Conduct Accompanied Field Visits and oversee project finances in smaller regions when necessary.

• Communicate with study sites about protocols, patient participation, case report forms, and any study-related issues.

• Coordinate study start-up activities, ensuring timely submissions to ethics committees and regulatory bodies when applicable.

• Guarantee that essential document quality aligns with Regulatory Compliance Review standards.

• Review and address queries from ethics committees.

• Provide insights for clinical activity forecasting estimates.

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

⛳️ Requirements

• Bachelor's degree or equivalent, along with relevant formal academic or vocational qualifications.

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

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

• Strong leadership, mentoring, training, motivation, and team integration capabilities.

• Excellent planning and organizational skills.

• Solid interpersonal and problem-solving abilities.

• Capacity to function effectively in a dynamic environment with complex or ambiguous situations.

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

• Strong judgment and decision-making capabilities.

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

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

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

• Exceptional attention to detail.

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

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

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

🏝️ Benefits

• Global team atmosphere.

• Opportunities for collaboration and professional development.

• Exposure to passion, innovation, and scientific excellence.

• Full-time employment status.

• Fully remote work arrangement.