Senior Clinical Data Manager

Accountabilities: Lead clinical data management activities for assigned clinical trials and programs, serving as the primary data management contact and ensuring continuity, responsiveness, and timely delivery. Oversee the clinical data entry process, including the development of data entry guidelines, personnel training, quality checks, and resource planning. Develop Case Report Form (CRF) specifications based on clinical study protocols and coordinate reviews and feedback from relevant stakeholders. Oversee clinical database development, user acceptance testing (UAT), database quality, and controlled documentation of database builds. Define and oversee edit check specifications and manual data review requirements to support accurate and consistent clinical data collection. Create, revise, version-control, and maintain data management documentation, ensuring completeness and appropriate filing within the Trial Master File. Review clinical trial data and generate queries in accordance with the Data Management Plan, including line listing reviews and patient- and study-level status and metric reporting. Perform or oversee medical coding and terminology consistency checks, including reconciliation of serious adverse events (SAEs) and adverse events (AEs). Coordinate with external data providers, electronic data capture (EDC) vendors, sponsors, and project teams to manage data-related deliverables, dependencies, and timelines. Monitor project metrics, audit findings, and stakeholder feedback to identify operational risks, troubleshoot issues, and implement appropriate solutions. Support the quality control of SAS programs and, where required, contribute to the review of study protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs). Contribute to the development and maintenance of Standard Operating Procedures (SOPs), work instructions, and process documentation for data and database management. Provide leadership across project teams and broader organizational initiatives, ensuring that team members receive appropriate training and understand study-specific requirements. Participate in sponsor and client meetings, strategy discussions, proposal reviews, bid defenses, capability presentations, and project estimation activities as needed. Deliver software demonstrations, training sessions, and project presentations, and undertake occasional travel when required. Requirements A bachelor's degree or an equivalent combination of relevant education and experience. At least 8 years of clinical data management experience for the Senior Clinical Data Manager level. The original description also identifies a Principal Clinical Data Manager level requiring at least 10 years of experience. Experience with clinical database management systems and a strong understanding of data management processes throughout the clinical trial lifecycle. Broad knowledge of drug, medical device, and/or biologic development, including effective clinical data management practices and applicable regulatory requirements. Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook. Excellent organizational, analytical, and problem-solving skills, with the ability to manage multiple tasks, project priorities, and deadlines. Strong leadership, interpersonal, and communication skills, including the ability to work effectively with sponsors, vendors, and multidisciplinary project teams. Professional proficiency in written and spoken English. Ability to identify project risks, assess resource requirements, monitor performance metrics, and maintain quality standards across clinical data deliverables. Preferred experience in a clinical, scientific, or healthcare discipline. Familiarity with medical coding dictionaries, particularly MedDRA and WHODrug. Understanding of CDISC standards, including CDASH, SDTM, and ADaM. Experience in oncology and/or orphan drug therapeutic areas is an advantage. Willingness and ability to undertake occasional business travel. Candidates must be legally authorized to work in the country of employment without requiring employer-sponsored work authorization. Benefits Remote work arrangement for candidates based in Brazil. Opportunity to contribute to clinical trials supporting the development of innovative therapies. Exposure to complex clinical data management programs and cross-functional clinical research teams. Opportunities to strengthen leadership capabilities and contribute to team training and organizational initiatives. Professional development through involvement in clinical database systems, regulatory standards, data quality practices, and process improvement. Collaboration with sponsors, external vendors, and multidisciplinary teams across the clinical research environment.