Job Description

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.