Data Manager

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

📋 Description

• Develop database schemas and submit commissioning requests to the EDC vendor.

• Program and configure structured electronic Case Report Forms (eCRFs) for patient-level studies and aggregated surveys at the center level.

• Set up lookup tables, establish field preconditions, standardize database column names, and create modular form structures.

• Oversee translations and configure welcome screens along with site instructions in secuTrial.

• Program automated field validations, define range limits, establish consistency rules, and create query messages.

• Generate and maintain Data Management Plans specific to projects utilizing Excel VBA macros.

• Configure automated notifications for Adverse Events and Off-Label Use.

• Conduct mandatory test data entry prior to production deployment.

• Authorize and validate automated production releases, back up project configurations, and produce annotated eCRFs.

• Set up settings and permissions for productive environments.

• Implement modifications to eCRFs mid-study without data loss and document all changes.

• Adapt survey structures for future waves or project cycles.

• Manage center profiles, user roles, and detailed data access rights.

• Execute staged database freezes, finalize database locks, and oversee Super-User closure.

• Archive project databases and protect study documentation in SharePoint.

• Conduct and document onboarding and technical training for EDC.

• Serve as a liaison among Project Management, Data Analysis, and Clinical Monitoring.

• Write, review, and update DMO Standard Operating Procedures (SOPs) and Work Instructions (WIs).

⛳️ Requirements

• A minimum of a bachelor's degree in medical information management or a related field.

• Preferably, professional training as a medical documentarist, medical information manager, or an equivalent qualification.

• Experience with electronic data capture (EDC) systems is essential.

• Knowledge of HTML, Java, and SQL is beneficial.

• A strong interest in oncology and a willingness to learn treatment guidelines for specific indications.

• Ability to work flexibly in a goal-oriented manner.

• Strong collaboration skills within a team setting.

• Proficiency in German and English at a business level.

• A master's degree in medical information management is preferred.

• Ability to quickly learn new topics, with an interest in healthcare data environments such as GxP being a plus.

• Additional language skills beyond German and English would be advantageous.

🏝️ Benefits

• Equal Opportunity Employer.

• Participation in E-Verify.

• Fully remote work with no expected travel.