Clinical Data Manager II – Senior Clinical Data Manager

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Oversee and manage all elements of the clinical trial data management process from the initiation of the study through to post-database lock for designated projects.

• Serve as the primary Data Management (DM) contact (Lead DM role) for assigned clinical projects/programs, ensuring backup, continuity, responsiveness, and timely execution of tasks.

• Supervise the project data entry process, which includes developing data entry guidelines, providing training, ensuring data entry quality, and managing resources.

• Provide insights, evaluate, and manage timelines to guarantee that clinical data management deadlines are met with high quality.

• Conduct User Acceptance Testing (UAT) for database builds and maintain documentation for quality-controlled database builds. Ensure overall quality of the clinical database.

• Responsible for the creation, revision, proper versioning, and maintenance of data management documentation. Ensure the completeness of data management documentation for the Trial Master File.

• Train clinical research staff on specific study-related CRFs, EDC, and other project-related materials as required.

• Review and query clinical trial data in accordance with the Data Management Plan.

• Perform line listing data reviews based on guidance from the sponsor and/or Lead DM.

• Collaborate with third-party vendors, such as external data and EDC providers, in a project management role to support timelines and data-related deliverables.

• Identify and resolve operational challenges, issues, obstacles, and barriers for studies using metrics data, audit reports, and feedback from project team members and other stakeholders.

⛳️ Requirements

• Bachelor's degree and/or a combination of relevant experience.

• 8+ years of experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II within a Clinical Research Organization, Pharmaceutical, or Biotech company.

• Experience in setup and database migrations.

• Oncology experience is preferred.

• Proficient in Microsoft Office: Word, Excel, PowerPoint, Outlook.

• Exceptional organizational and communication skills.

• Professional command of the English language, both written and spoken.

• Familiarity with various clinical database management systems.

• Comprehensive knowledge of drug, device, and/or biologic development along with effective data management practices.

• Strong representational skills with the ability to communicate effectively both orally and in writing.

• Strong leadership and interpersonal abilities.

• Willingness to travel occasionally.

🏝️ Benefits

• N/A