Job DescriptionUnder 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 documentationEnsure collation and distribution of study tools and documentsUpdate clinical trial databases (CTMS) and study trackersSupport management and tracking of clinical and non-clinical supplies in collaboration with other country rolesCoordinate labeling requirements and translation change requests, when applicableMonitor supply-related activities to support uninterrupted study conduct• Document Management:Prepare study documents and correspondenceCollate, distribute/ship, and archive clinical documents, including eTMF documentationAssist with eTMF reconciliation activitiesExecute eTMF Quality Control Plan Update study manuals, patient materials, and instructions as requiredMaintain records related to investigational product and supply managementDocument and track proper destruction of clinical supplies in compliance with applicable procedureso Ensure compliance with Good Documentation Practices (GDP) • Investigational Product & Supply Management:Support forecasting, tracking, and management of investigational product and study suppliesCoordinate clinical and non-clinical supply activities to support study timelinesMonitor inventory records and supply documentationSupport labeling and packaging activities, including translation requirements where applicableEnsure supply-related documentation is maintained accurately and compliantlyAssist with supply issue resolution and escalation as needed • Quality & Oversight:Act as a Subject Matter Expert (SME) for designated processes and systemsShare best practices and contribute to continuous process improvement initiativesProvide training, guidance, and support to team members as requiredMentor and buddy junior CTCs on process requirements and operational activitiesSupport 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-DNIRequired 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: Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:No Travel RequiredFlexible Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:09/3/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.