Clinical Data Manager II/Senior Clinical Data Manager

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

📋 Description

• Responsible for managing all elements of the clinical trial data management process.

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

• Oversee the data entry process for projects, including the development of data entry guidelines.

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

• Perform quality control checks on data entry.

• Train clinical research staff on study-specific Case Report Forms (CRFs).

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

• Collaborate with third-party vendors, including external data and Electronic Data Capture (EDC) vendors, in a project management role.

• Identify and resolve operational challenges and issues.

• Contribute to the development and upkeep of Standard Operating Procedures (SOPs).

⛳️ Requirements

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

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

• Experience in setting up and migrating databases.

• Oncology experience is preferred.

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

• Excellent organizational and communication abilities.

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

• Experience with various clinical database management systems.

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

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

• Strong leadership and interpersonal skills.

• Willingness to travel occasionally.

🏝️ Benefits

• Discretionary annual bonus.

• Private medical insurance.

• MultiSport Card.

• Life insurance.

• Pension plan.

• Home working allowance.

• Vacation time.