Senior 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 moderate- to high-complexity studies, ensuring compliance with ICH GCP.

• Take on roles such as Regional Lead CTM, Clinical Study Manager, and responsibilities related to process enhancement, program management, or project coordination as designated.

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

• Establish, organize, maintain, and archive pertinent Trial Master File documents and study materials.

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

• Prepare, organize, and deliver presentations at client meetings, including bid defense and hand-off sessions.

• Work collaboratively with clinical teams and other departments, lead team meetings, and oversee timelines, resources, interactions, and quality.

• Execute and provide training on standardized clinical monitoring processes.

• Track clinical activity timelines and metrics, furnish project status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution.

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

• Coordinate study initiation activities, regulatory submissions, and follow-ups with ethics committees as necessary.

• Contribute to forecasts of clinical activities.

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

• Conduct accompanied site visits and handle project financials when necessary.

• Carry out limited line management duties on assigned GPHS projects within North America.

⛳️ Requirements

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

• Over 8 years of prior experience providing the necessary knowledge, skills, and abilities to fulfill the job requirements.

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

• Strong skills in leadership, mentoring, training, planning, organization, interpersonal relations, problem-solving, judgment, decision-making, escalation, risk management, financial acumen, and attention to detail.

• Familiarity with change management principles.

• Extensive understanding of clinical monitoring practices, processes, and requirements.

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

• Knowledge of budgeting, forecasting, and financial management.

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

• Strong computer proficiency, including Outlook, Excel, Word, and other computerized applications.

• Ability to independently manage clinical-only studies.

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

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and development.

• Work environment focused on scientific excellence.