Senior Clinical Data Manager

Jobgether; Brasil; Remote; BRL 260,000 - 420,000; Full time

Benefits offered by this job

Remote work in Brazil

Professional development

Job summary

Jobgether in Brazil seeks a Senior Clinical Data Manager to lead clinical data management across trials from start-up through post-database lock, ensuring data accuracy and regulatory compliance for innovative therapies. You will coordinate CRF specifications, database development, data review, and documentation, working with sponsors, vendors, and cross-functional teams.

This remote role supports a growing Latin American data management group.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• At least 8 years of clinical data management experience for Senior level.
• Experience with clinical database management systems and data management processes.
• Broad knowledge of drug, medical device, and/or biologic development, including regulatory requirements.
• Proficiency in Microsoft Office applications.
• Excellent organizational, analytical, and problem-solving skills.
• Strong leadership, interpersonal, and communication skills.
• Professional proficiency in written and spoken English.
• Ability to identify project risks, assess resources, monitor performance metrics, and maintain quality.
• Preferred experience in a clinical, scientific, or healthcare discipline.
• Familiarity with MedDRA and WHODrug.
• Understanding of CDISC standards (CDASH, SDTM, ADaM).
• Experience in oncology and/or orphan drug therapeutic areas is an advantage.
• Willingness for occasional business travel.
• Candidates must be legally authorized to work in the country of employment.

Responsibilities

• Lead clinical data management activities for assigned trials as primary data management contact.
• Oversee data entry process, data guidelines, training, quality checks, and planning.
• Develop CRF specifications based on study protocols and coordinate reviews.
• Oversee database development, UAT, database quality, and documentation.
• Define and oversee edit checks and data review requirements.
• Maintain data management documentation in the Trial Master File.
• Review trial data and generate queries per the Data Management Plan.
• Coordinate with external data providers, EDC vendors, sponsors and teams.
• Monitor project metrics, audit findings, and stakeholder feedback to identify risks and implement solutions.
• Support QC of SAS programs and review study protocols, SAPs, and CSRs when required.
• Contribute to SOPs, work instructions and process documentation for data management.
• Provide leadership across project teams and training to staff.
• Participate in sponsor and client meetings, strategy discussions, and project estimation.

Skills

Clinical Data Management

Leadership & Team Coordination

Regulatory Compliance

Project Management

Communication Skills

English Proficiency

Problem Solving

Microsoft Office Suite

Education

Bachelor's degree or equivalent in a relevant field

Tools

EDC systems

SAS

Microsoft Office

Job description

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Clinical Data Manager based in Brazil.

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.