Senior Clinical Trial Manager, FSP

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

📋 Description

• Oversee the clinical operational and quality aspects of studies that range from moderate to high complexity, ensuring adherence to ICH GCP standards.

• Take on roles such as Lead Clinical Trial Manager, Clinical Study Manager, process improvement specialist, program manager, or project coordinator as assigned.

• Create clinical tools, including Monitoring Plans and Monitoring Guidelines, aligned with the Data Quality Plan.

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

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

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

• Lead clinical team meetings, coordinating timelines, resources, interactions, and maintaining quality standards.

• Implement and educate teams on standardized clinical monitoring processes.

• Ensure that study documents and materials are archived in a timely manner.

• Keep track of clinical activity timelines and metrics, provide updates on project status, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution.

• Oversee trial performance and ensure compliance with contractual obligations.

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

• Maintain communication with study sites regarding protocols, patient participation, case report forms, and related study issues.

• Coordinate study start-up activities and regulatory submissions as necessary.

• Review and respond to ethics committee inquiries.

• Prepare forecast estimates for clinical activities.

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

• Provide limited line management for assigned Government & Public Health Studies projects in North America.

⛳️ Requirements

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

• At least 8 years of prior experience demonstrating relevant knowledge, skills, and abilities.

• An equivalency that combines relevant education, training, and/or directly related experience may be considered.

• Excellent leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, and risk-management capabilities.

• Strong grasp of change management principles.

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

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

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

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

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

• Ability to independently manage clinical-only studies.

• Willingness to travel frequently to domestic and international site locations.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday to Friday work schedule.

• Opportunities for collaboration and professional development.

• Access to mentoring and training programs.

• Experience working in a global team environment.

• Opportunities for domestic and international travel.