Clinical Data Manager II – Senior Clinical Data Manager

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

📋 Description

• Accountable for overseeing all elements of the clinical trial data management process from the initiation of the study to the post-database lock phase.

• Serve as the primary Data Management (DM) point of contact for designated clinical project(s), ensuring seamless operations and timely execution of tasks.

• Supervise the data entry process for projects, which includes creating data entry guidelines, providing training, and ensuring quality.

• Offer insights, evaluate, and manage timelines to guarantee adherence to clinical data management deadlines.

• Create CRF specifications based on clinical study protocols and facilitate feedback from stakeholders.

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

• Define requirements for all types of edit checks and oversee the development of those specifications.

• Educate clinical research staff on project-related topics.

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

• Generate patient and study-level status reports and metrics.

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

• Act as a liaison with third-party vendors in a project management role.

• Identify and resolve operational issues based on metrics data.

⛳️ Requirements

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

• Over 8 years of experience as a Senior Clinical Data Manager or at least 5 years as a Clinical Data Manager II in a Clinical Research Organization, Pharmaceutical, or Biotech company.

• Experience with database setup and migrations.

• Preferred experience in oncology.

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

• Outstanding organizational and communication skills.

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

• Familiarity with various clinical database management systems.

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

• Strong representational skills and the ability to communicate effectively in both oral and written formats.

• Excellent leadership and interpersonal capabilities.

• Willingness to undertake occasional travel.

🏝️ Benefits

• Opportunities to work from home.

• Flexible work arrangements.