Sr. Clinical Trial Coordinator - Regulatory & Site Start-Up - São Paulo (SP)

Job description

Job Description Under the oversight of the line manager, this role is responsible for supporting and coordinating Regulatory and Site Start-Up activities, trial administration, and clinical document management. The Sr. CTC - Regulatory ensures timely regulatory submissions, maintenance of essential study documentation, and compliance with applicable regulations and company procedures. The role is critical to achieving planned Site Ready dates and maintaining inspection-ready documentation throughout the study lifecycle. The position collaborates closely with Clinical Operations, CRAs, investigators, Ethics Committees, Regulatory Authorities, and other cross-functional stakeholders. Responsibilities include, but are not limited to: • Trial and Site Administration Track essential documents and study reports. Ensure distribution and maintenance of study tools and documentation. Update CTMS, trackers, and other clinical systems. • Document Management Prepare, distribute, and archive clinical trial documentation. Support eTMF maintenance, reconciliation, and quality control activities. Prepare Investigator Site Files and coordinate document translations. Ensure compliance with Good Documentation Practices (GDP). • Regulatory & Site Start-Up Support collection and management of site start-up documentation. Prepare and track submissions to Ethics Committees (IRB/ERC) and Regulatory Authorities. Maintain study insurance documentation and regulatory trackers. Support site activation activities and publication of study results when required by local regulations. • Quality & Oversight Act as a Subject Matter Expert (SME) for selected processes. Support continuous improvement initiatives and best practice sharing. Mentor and provide guidance to junior CTC team members. Main Requirements: Bachelor's Degree required. Fluent in Portuguese and business proficient in English. Experience in Regulatory Affairs, Site Start-Up, Clinical Trial Administration, or related clinical research functions. Strong knowledge of ICH-GCP, Good Documentation Practices (GDP), and local regulatory requirements. Experience with CTMS, eTMF, and Microsoft Office applications. Strong organizational, communication, and stakeholder management skills. Ability to manage multiple priorities in a fast-paced environment. Ability to work independently and effectively within a matrix and multicultural environment. #ClinicalTrialsBR #LI-DNI Required Skills: Adaptability, Adaptability, Building Capability, Clinical IT, Clinical Reporting, Clinical Research, Clinical Research Management, Clinical Study Design, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Management, Clinical Trials Monitoring, Customer-Focused, Data Analysis, Document Management, Document Management Software, Electronic Trial Master File, Good Clinical Data Management Practice (GCDMP), ICH GCP Guidelines, New Technology Integration, Procedure Manuals, Project Management, Quality Compliance, Quality Control Management, Quality Management Systems (QMS) {+ 8 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search 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: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N.A Job 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.