Sr. Clinical Trial Coordinator (CTC) - Investigational Product & Supplies (I&S) - São Paulo (SP)

Under the oversight of the line manager, this role is responsible for supporting and coordinating Investigational Product and Supply Management activities, trial administration, and clinical document management. The Sr. Clinical Trial Coordinator (CTC) – Investigational Product & Supplies (I&S) ensures timely management of clinical and non-clinical supplies, supports labeling activities, maintains essential study documentation, and ensures compliance with applicable regulations, Good Clinical Practice (GCP), and company procedures.
The role is critical to ensuring study continuity through effective supply management and maintenance of inspection-ready documentation throughout the clinical trial lifecycle. The position collaborates closely with Clinical Operations Managers (COM), Clinical Research Managers (CRM), Clinical Research Associates (CRA), Supply Chain teams, vendors, investigators, and other cross-functional stakeholders.

Responsibilities include, but are not limited to:

• Trial and Site Administration:

• Track essential documents and study reports, including safety-related documentation
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and study trackers
• Support management and tracking of clinical and non-clinical supplies in collaboration with other country roles
• Coordinate labeling requirements and translation change requests, when applicable
• Monitor supply-related activities to support uninterrupted study conduct

• Document Management:

• Prepare study documents and correspondence
• Collate, distribute/ship, and archive clinical documents, including eTMF documentation
• Assist with eTMF reconciliation activities
• Execute eTMF Quality Control Plan
• Update study manuals, patient materials, and instructions as required
• Maintain records related to investigational product and supply management
• Document and track proper destruction of clinical supplies in compliance with applicable procedures
• o Ensure compliance with Good Documentation Practices (GDP)
  

• Investigational Product & Supply Management:

• Support forecasting, tracking, and management of investigational product and study supplies
• Coordinate clinical and non-clinical supply activities to support study timelines
• Monitor inventory records and supply documentation
• Support labeling and packaging activities, including translation requirements where applicable
• Ensure supply-related documentation is maintained accurately and compliantly
• Assist with supply issue resolution and escalation as needed
  

• Quality & Oversight:

• Act as a Subject Matter Expert (SME) for designated processes and systems
• Share best practices and contribute to continuous process improvement initiatives
• Provide training, guidance, and support to team members as required
• Mentor and buddy junior CTCs on process requirements and operational activities
• Support inspection readiness through quality-focused documentation and process compliance
  

Main Requirements:

• Bachelor’s Degree;
• Fluent in Portuguese and business proficient in English (verbal and written);
• Experience in Clinical Research, Clinical Trial Administration, Supply Management, or related functions;
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines;
• Hands-on knowledge of Good Documentation Practices (GDP);
• Knowledge of Trial Master File (TMF/eTMF) management processes;
• Experience supporting investigational product and clinical supply activities is preferred;
• Good Information Technology skills, including Microsoft Office applications;
• International Conference on Harmonisation Good Clinical Practice (ICH-GCP) knowledge appropriate to the role;
• Strong organizational, communication, and stakeholder management skills;
• Effective time management and ability to manage multiple priorities simultaneously;
• High sense of accountability, quality focus, and attention to detail;
• Ability to work independently and effectively in a matrixed multicultural environment;
• Demonstrated commitment to customer focus, both internally and externally;
• Experience mentoring or supporting junior team members is preferred.

#ClinicalTrialsBR
#LI-DNI

Required Skills:

Adaptability, Adaptability, Building Capability, Clinical IT, Clinical Research, Clinical Research Management, Clinical Study Design, Clinical Supplies Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Management, Clinical Trials Monitoring, Customer-Focused, Data Analysis, Data Destruction, Document Automation, Document Management, Document Management Software, Document Productions, Filing Documents, Good Clinical Data Management Practice (GCDMP), Hazardous Waste Disposal, ICH GCP Guidelines, Legal Systems, New Technology Integration {+ 9 more}

Preferred Skills:

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