Clinical Trial Manager, Regulatory Experience

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

📋 Description

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits either on-site or remotely.

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and protocol compliance.

• Assess site and site staff performance, recommending actions specific to each site.

• Confirm informed consent processes and safeguard subject/patient confidentiality.

• Evaluate subject/patient safety, the integrity of clinical data, protocol deviations/violations, and pharmacovigilance matters.

• Perform source document reviews and verify clinical data recorded in CRFs.

• Address queries both remotely and on-site within established timelines.

• Assist in clinical project data review and capture using available hardware and software tools.

• Ensure compliance with electronic data capture standards.

• Oversee investigational product inventory, including reconciliation, storage, dispensing, and administration as required.

• Review Investigator Site Files and ensure they align with Trial Master Files.

• Document activities through letters, trip reports, communication logs, and project documentation.

• Aid in subject/patient recruitment, retention, and awareness initiatives.

• Monitor observations, ongoing statuses, and ensure action items are resolved.

• Manage site-level activities and communications to achieve project goals, deliverables, and timelines.

• Serve as a liaison with project site personnel, ensuring assigned sites and team members are adequately trained and compliant.

• Participate in investigator and sponsor meetings, global monitoring/project meetings, and clinical training sessions.

• Facilitate audit readiness, preparation, and follow-up actions.

• For Real World Late Phase: provide site support throughout the study lifecycle, perform chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons, and local country staff.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory standards.

• Proficient computer skills and a willingness to adopt new technologies.

• Strong communication, presentation, and interpersonal abilities.

• Capacity to manage travel requirements of up to 75% on a regular basis.

• Working knowledge of pertinent regulations and company SOPs/processes.

• For Real World Late Phase: understanding of local requirements for real-world late-phase study designs.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Emphasis on a Total Self culture.

• A workplace focused on diversity, inclusion, and belonging.