Clinical Data Manager (m/f/d)

Permanent employee,Full-time· Planegg (Germany), Remote (Germany)

Be part of our team

As ourClinical Data Manager (CDM) (m/f/d) you are an essential contributor to the successful execution of clinical trials, ensuring the integrity, accuracy, completeness, and quality of the clinical data from trial design through final database lock. This role partners cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Safety/ Pharmacovigilance, Regulatory Affairs, and CROs and external vendors to design, develop and implement a robust data management process that supports high-quality outcomes, timely database locks, and seamless data handoffs for reporting, analysis, and regulatory submission.

Your mission

• 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.
• Contribute to continuous improvement activities, including SOP development and implementation of best practices in clinical data management.

Your profile

• Bachelor’s degree in life sciences, health informatics, or related field, advanced degree preferred.
• At least 2 years of clinical data management experience in both early- and late-phase global trials in a biotech, pharmaceutical, or CRO environment.
• 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.

Why us?

Flat hierarchies and short decision-making processes; open corporate culture; possibility of mobile working; unlimited contract after probationary period; 30 days\' vacation; strong team spirit; personal appreciation of values; multicultural and global team and high level of collegiality; regular team events; mobility allowance; pleasant office atmosphere, modern technology standard.

The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and antibody-drug conjugates (ADCs). With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.