Clinical Trial Manager CTM - Argentina, Brazil

Description

Clinical Trial Manager with experience working with United States as a CTM – Argentina, Brazil, Chile, Colombia or Mexico. Home Based.

• Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP, GPP, and protocol compliance; evaluate overall site performance and provide recommendations; communicate/escalate serious issues.
• Verify informed consent process and documentation for each subject; protect confidentiality and assess factors affecting safety and data integrity.
• Implement the Clinical Monitoring/Site Management Plan: conduct source document review, verify CRF data accuracy, resolve queries, support electronic data capture compliance.
• Manage investigational product inventory, reconciliation, dispensing, and security; ensure proper labeling, storage, and return.
• Review the Investigator Site File for accuracy, reconcile with Trial Master File, ensure archiving per local regulations.
• Document activities via letters, logs, and reports; support recruitment, retention, and data entry into tracking systems.
• Understand project scope, budgets, timelines; manage site‑level activities; adapt to changing priorities with oversight of Lead CRA.
• Act as liaison with site personnel; ensure training and compliance.
• Prepare for and attend investigator meetings, sponsor meetings, clinical training sessions.
• Provide guidance towards audit readiness; support audit preparation and follow‑up actions.
• For Real World Late Phase, provide site support, chart abstraction, data collection, and collaboration with sponsor affiliates and local staff.

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
• Knowledge of GCP/ICH Guidelines and other regulatory requirements.
• Good computer skills and ability to adopt new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to travel up to 75% of the time.
• US‑only requirement:
  Compliance with site information and access procedures.

Roles within the Clinical Trial Management job family oversee the development, coordination, and implementation of Phase 1 clinical research studies. Responsibilities include collaborating with principal investigators, serving as liaisons, planning logistics and resources, tracking study progress, managing budgets, and ensuring compliance with regulations. The company is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations as appropriate.