Tubulis GmbH

Data Scientist

• Lead data management activities from initiation through database lock.
• Develop, review and maintain core data management documents, including Data Management Plans, CRFs, Edit Check Specification, Data Transfer Plans, Data Review Guidelines.
• Ability to drill down into data irregularities and resolve issues with data miscoding, missingness, or analysis errors.
• Collaborate with internal teams and external vendors to define EDC specifications, ensure accurate CRF build, execute data cleaning activities (e.g. query resolution, SAE reconciliation, coding review), and manage the reconciliation and integration of external data sources (e.g., central labs, imaging, ePRO) into the study database.
• Facilitate cross-functional data review meetings and ensure timely resolution of data discrepancies.
• Oversee database lock planning and execution while managing CROs and external vendors to ensure all data deliverables meet project standards, timelines, and requirements for statistical analysis and regulatory submission.
• Track milestones and deliverables, and manage escalation and resolution of issues.

Clinical Data Manager

Manager

• Oversight and responsibility (review, assessment, and approval) for stability studies of critical reagents, ADC intermediates, drug substance, and drug product from all projects within Tubulis.
• Support phase-appropriate analytical method qualification/validation at contract manufacturing organizations and support method transfer.
• Interpretation of in-house analytical data, including result documentation/certification, for both internal and external material according to our platform.
• Handling of changes, deviations, and OOX.
• Contribute to specifications for intermediates, drug substance, and drug product.
• Contribute to comparability studies.

Clinical Data Manager

QC Manager