Clinical Data Manager

Clinical Data Manager

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

As a Clinical Data Manager, you will play a central role in ensuring the quality, integrity, and reliability of clinical trial data throughout the study lifecycle. You will serve as a key data management contact for assigned clinical projects, coordinating activities from study start-up through database lock and beyond. The role combines clinical research expertise, database management, data review, and cross-functional project coordination. You will collaborate with sponsors, project teams, vendors, and clinical research personnel to keep data management activities accurate and on schedule. You will also contribute to database development, testing, reconciliation, reporting, and continuous process improvement. This is an opportunity to take ownership of complex clinical data activities while supporting studies that help advance new therapies and healthcare solutions.

Accountabilities:

• Serve as the primary Data Management contact for assigned clinical projects or programs, ensuring continuity, responsiveness, quality, and timely delivery of data management activities.
• Oversee clinical data entry processes, including data entry guidelines, training, quality control, resourcing, and adherence to study-specific requirements.
• Develop and maintain Case Report Form (CRF) specifications based on clinical study protocols and coordinate reviews with relevant stakeholders.
• Support or oversee clinical database development, user acceptance testing, edit check specifications, manual data review specifications, and controlled database documentation.
• Ensure the overall quality, completeness, and consistency of clinical databases and associated data management documentation.
• Develop, maintain, revise, and appropriately version data management documentation, including materials required for the Trial Master File.
• Review and query clinical trial data in accordance with Data Management Plans and perform line-listing reviews based on sponsor and project guidance.
• Monitor patient- and study-level metrics, generate status reports, and use data to identify and troubleshoot operational risks, issues, and barriers.
• Coordinate adverse event and serious adverse event reconciliation and support medical coding activities using appropriate coding dictionaries.
• Liaise with external data, EDC, and other third-party vendors to coordinate data-related deliverables, timelines, and project requirements.
• Support financial and operational planning by assessing timelines, resource requirements, and data management deliverables for assigned studies.
• Provide training to clinical research personnel and project team members on CRFs, EDC systems, study-specific processes, and other relevant data management activities.
• Collaborate with sponsors, project teams, vendors, and other stakeholders to resolve data, database, and project-related issues.
• Contribute to the development and maintenance of Standard Operating Procedures and process documentation related to clinical data and database management.
• Provide leadership on cross-functional or organization-wide initiatives and contribute to process improvement efforts.
• Support proposals, project estimates, client presentations, strategy meetings, and other business development activities when required.
• Mentor and support data management team members while promoting consistent standards, effective collaboration, and timely delivery.
• Perform other clinical data management duties and occasional travel as required by project needs.

Requirements:

• Bachelor's degree or an equivalent combination of relevant education and professional experience.
• At least 8 years of clinical data management experience for Senior-level positions or 10+ years for Principal-level positions.
• Proven experience working with clinical database management systems and clinical trial data management processes.
• Broad understanding of drug, medical device, and/or biologic development and established clinical data management practices.
• Professional proficiency in English, with strong written and verbal communication skills.
• Strong proficiency in Microsoft Office, particularly Word, Excel, PowerPoint, and Outlook.
• Strong organizational and time management abilities, with the capacity to manage multiple clinical research activities and competing deadlines.
• Strong analytical and problem-solving skills, including the ability to assess data, identify inconsistencies, investigate issues, and communicate results clearly.
• Demonstrated leadership and interpersonal skills, with the ability to coordinate cross-functional teams and maintain productive relationships with sponsors, vendors, and project stakeholders.
• Experience with medical coding dictionaries such as MedDRA and WHODrug is preferred.
• Knowledge of CDISC standards, including CDASH, SDTM, and ADaM, is preferred.
• Experience in oncology and/or orphan drug therapeutic areas is an advantage.
• Clinical, scientific, or healthcare experience is preferred.
• Ability to work independently while also contributing effectively within a collaborative, international project environment.
• Willingness and ability to travel occasionally when required.

Benefits:

• Remote work opportunity based in Brazil.
• Opportunity to contribute to clinical research programs supporting the development of innovative therapies.
• Exposure to global clinical trials, sponsors, vendors, and cross-functional research teams.
• Opportunity to take ownership of complex clinical data management activities across the full study lifecycle.
• Professional growth through collaboration with experienced clinical research, data management, and project teams.
• Opportunities to contribute to process improvement, organizational initiatives, and data management best practices.
• Collaborative environment focused on quality, accuracy, accountability, and continuous improvement.
• Opportunity to mentor colleagues and develop leadership capabilities within clinical data management.