Senior Clinical Data Manager

Senior Clinical Data Manager

We are seeking an experienced Senior Clinical Data Manager to lead clinical data management activities across clinical trials, from study start-up through post-database lock. In this role, you will help ensure the accuracy, integrity, completeness, and quality of clinical data supporting the development of innovative therapies. You will serve as a primary data management contact for assigned studies, coordinating database development, testing, data review, and documentation in line with regulatory requirements and study protocols. Working closely with sponsors, cross-functional teams, and external vendors, you will oversee project timelines, resolve operational challenges, and maintain high-quality deliverables. You will also contribute to team development, process improvement, and the implementation of consistent data management practices. This remote opportunity offers the chance to help strengthen a growing Latin American data management team while supporting complex clinical research programs.

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.