Clinical Data Manager – Senior
Tubulis GmbH
full-time
Posted on:
Location Type: Remote
Location: Germany
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Job Level
Tech Stack
About the role
- Lead clinical data management activities from study 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.
- 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.
- Contribute to continuous improvement activities, including SOP development and implementation of best practices in clinical data management.
Requirements
- Bachelor’s degree in life sciences, health informatics, or related field is required; an advanced degree is preferred.
- At least 3+ years of clinical data management experience (5+ years for Senior Clinical Data Manager) in both early- and late-phase global trials in a biotech or pharmaceutical environments is required.
- Solid understanding of GCP/ICH guidelines, regulatory requirements, and industry best practices in clinical data management.
- Proficiency with EDC systems (i.e., Medidata Rave), including integration with Spotfire and familiarity with CDISC standards (SDTM), and clinical coding dictionaries (e.g., MedDRA, WHODrug).
- Excellent organizational, analytical, and communication skills, with a demonstrated ability to troubleshoot and resolve data-related issues.
- Ability to thrive both independently and collaboratively in a fast-paced, cross-functional environment.
- High attention to detail with a strong commitment to data accuracy, integrity, and quality.
- Oncology trial experience is a plus.
- Experience working in clinical operations is a plus.
Benefits
- Impact that matters : Contribute to breakthrough therapies.
- Global mindset : Work in an international, diverse team.
- Grow & thrive : Develop your career in a supportive, fast-moving environment.
- Innovation every day : Push boundaries with cutting-edge science.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical data managementdata management plansCRFsdata cleaningquery resolutionSAE reconciliationcoding reviewGCPICH guidelinesCDISC standards
Soft Skills
organizational skillsanalytical skillscommunication skillstroubleshootingattention to detailcommitment to data accuracycollaborative skillsindependent workingproblem-solvingcross-functional teamwork