Clinical Data Manager II – Senior Clinical Data Manager

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

📋 Description

• The Clinical Data Manager II/Senior Clinical Data Manager oversees and manages all facets of the clinical trial data management process, from study initiation to post-database lock for designated projects.

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

• Ensure that clinical data management deadlines are met with a focus on quality.

• Conduct user acceptance testing for database builds and maintain documentation for quality-controlled database builds.

• Contribute to, evaluate, and manage timelines.

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

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

⛳️ 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 working in a Clinical Research Organization, Pharmaceutical, or Biotech company.

• Experience with setup and database migrations.

• Oncology experience is preferred.

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

• Exceptional organizational and communication skills.

• Professional proficiency in English, both written and spoken.

• Experience 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 in both oral and written forms.

• Strong leadership and interpersonal abilities.

• Willingness to undertake occasional travel.

🏝️ Benefits

• Clinical Trial Services

• Professional development opportunities