Clinical Trial Manager – Oncology

This is a fully remote position, open to applicants in Mexico, +4 more countries.

📋 Description

• Oversee the execution of clinical study site management activities by coordinating Clinical staff within a designated geographic area.

• Ensure that site qualification, initiation, interim monitoring, site management, and study close-out activities adhere to the protocol, study plan, and Worldwide SOPs.

• Guarantee the quality and promptness of clinical deliverables for assigned programs or regions.

• Collaborate with Project Management to define site-management objectives and monitoring strategies.

• Provide leadership and guidance to the clinical site-management team from the beginning of the study until its closure.

• Act as the primary Site Management liaison for clinical monitoring and site-related activities.

• Manage monitoring deliverables, study budgets, out-of-scope activities, and quality-management documents such as Clinical Monitoring Plans.

• Supervise adherence to the Clinical Monitoring Plan, site visits, trip reports, follow-up letters, protocol deviations, and action items from visits.

• Train Clinical Research Associates (CRAs) on the clinical aspects of studies.

• Develop and execute patient-recruitment strategies and monitor enrollment progress.

• Enhance the quality of site data, review data metrics, and resolve issues with action plans.

• Monitor site-management deliverables, trends, analytics, financial performance, resource allocation, and time recognition.

• Ensure compliance with the Trial Master File and readiness for inspections.

• Create a regional monitoring strategy and anticipate site visit and staffing requirements.

• Review and finalize trip reports.

• Conduct site qualification, initiation, interim monitoring, and close-out visits as necessary.

• Address monitoring and site issues by escalating them, proposing solutions, and mitigating risks.

• Represent Site Management as the primary project contact when required.

• Conduct co-visits to verify the quality of site, CRA, and study procedures.

⛳️ Requirements

• Exceptional interpersonal, oral, and written communication skills in English; proficiency in Portuguese is preferred.

• Strong planning, organizational, presentation, and time-management abilities.

• Capability to handle multiple tasks, negotiate diplomatically, prioritize effectively, plan proactively, and work with minimal supervision.

• Ability to lead and inspire a remote team.

• Experience and input in monitoring and site management process initiatives.

• Strong customer focus and professional interaction with sponsors.

• Extensive knowledge of clinical research principles and processes.

• Comprehensive understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements.

• Experience in the relevant therapeutic indication/area of the study.

• In-depth familiarity with standard operating procedures.

• Proficient in Microsoft Office, eCRF, and IVRS packages.

• Skilled in using IxRS, CTMS, and EDC systems.

• A four-year degree or equivalent in biological, physical, or health studies with at least three years of experience as a Senior Clinical Research Associate (or equivalent), OR a two-year degree or equivalent education/training with at least five years as a Senior Clinical Research Associate, or at least six months in a CTM/LCRA (or equivalent) role while supporting the main CTM and coordinating clinical operations activities.

• A valid current passport is required.

• A driving license is required.

• Travel is required.

🏝️ Benefits

• Equal opportunity for employment.

• A diverse and inclusive work environment.

• A supportive, team-oriented atmosphere.

• Accessible and hands-on leadership.

• Opportunities for professional growth and success.