Senior Clinical Data Manager II

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

📋 Description

• Responsible for managing all facets of the clinical trial data management process from the initiation of the study through to post database lock for assigned projects.

• Serve as the primary Data Management (DM) contact (Lead DM role) for designated clinical project(s) / program(s), ensuring backup, continuity, responsiveness, and timely task execution.

• Supervise the project data entry process, including the development of data entry guidelines, training, quality of data entry, and resource management.

• May conduct quality control assessments of data entry.

• Provide input, evaluate, and manage timelines, ensuring that clinical data management deadlines are achieved with a focus on quality.

• Perform User Acceptance Testing (UAT) for database builds and maintain documentation for quality-controlled database builds.

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

• Train clinical research personnel on study-specific Case Report Forms (CRF), Electronic Data Capture (EDC), and other project-related items as necessary.

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

• Coordinate the reconciliation of Serious Adverse Events (SAE) and Adverse Events (AE).

• Collaborate with third-party vendors, including external data and EDC vendors, in a project manager capacity to support timelines and data-related deliverables.

• Identify and resolve operational challenges, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members.

⛳️ Requirements

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

• Over 8 years of experience as a Senior Clinical Data Manager or more than 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 Suite: Word, Excel, PowerPoint, and Outlook.

• Exceptional organizational and communication skills.

• Professional proficiency in the English language, both written and spoken.

• Experience utilizing various clinical database management systems.

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

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

• Strong leadership and interpersonal skills.

• Willingness to undertake occasional travel.

🏝️ Benefits

• We welcome candidates based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.

• Competitive salary.