Clinical Trial Manager, FSP

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

📋 Description

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

• Create clinical tools, monitoring plans, guidelines, data quality plans, and other clinical-related documentation.

• Contribute to the development of Master Action Plans and ensure the quality and organization of Trial Master Files.

• Engage in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents.

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

• Collaborate with clinical and cross-functional teams to achieve project milestones.

• Lead team meetings, overseeing timelines, resources, interactions, and quality standards.

• Implement and provide training on standardized clinical monitoring processes to teams.

• Ensure the timely archiving of study documents and materials.

• Prepare and monitor timelines and metrics related to clinical activities, deliver project status updates, review tracking tools, and initiate recovery actions as necessary.

• Evaluate monitoring visit reports and manage the collection of CRFs and resolution of queries.

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

• Conduct Accompanied Field Visits and oversee project financials when required in smaller regions.

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

• Coordinate study start-up activities as well as submissions to ethics committees and regulatory bodies when appropriate.

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

• Contribute to clinical activity forecasts.

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

⛳️ Requirements

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

• A minimum of 5 years of prior experience providing the necessary knowledge, skills, and abilities to excel in the role.

• An equivalent combination of suitable education, training, and/or directly related experience may also be considered.

• Skills in leadership, mentoring, training, motivation, and team integration.

• Strong planning and organizational abilities.

• Interpersonal and problem-solving skills.

• Capability to operate within a multicultural matrix organization and adapt to changing environments with complex or ambiguous situations.

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

• Sound judgment and decision-making skills.

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

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

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

• Excellent attention to detail.

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

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

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

🏝️ Benefits

• Work within a global team environment.

• Opportunities for collaboration and professional development.

• Frequent domestic and international travel as part of job responsibilities.