Permanent employee, Full-time · Planegg-Martinsried

Your mission

Supports data management in the design of the EDC to ensure CRF designs adequately support data collection in alignment with protocol and to ensure complete and accurate data collection throughout the trial.
Plays a key role in the review of clinical study data to ensure timely and high-quality data entry, including the review of case report forms, patient profiles, biostatistical outputs, graphical representations, etc.
Assists in coding, analysis, and proper and complete documentation of clinical data.
Supports the Clinical Trial Lead and the Clinical Trial Manager to coordinate relevant and timely data analyses and presentations in collaboration with Data Management, Biostatistics, and Pharmacovigilance to prepare for Safety Review Committee meetings, Data Safety Monitoring Board meetings, regulatory documents, and internal data reviews to ensure timely program decisions.
Collaborates cross-functionally for the development of clinical trial protocols and informed consent forms and contributes to the review of other study-related documents (e.g., statistical analysis plan, CRF completion guidelines, etc.) to support the operational execution of clinical studies.
Develops site and CRA training materials and participates in the training of site and company staff.
Authors/reviews clinical contribution to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, Orphan Annual Reports).
Contributes to the development of data review plans in collaboration with Data Management.

Your profile

Advanced degree within life science or medicine (e.g. MD, MS, PhD, PharmD).
Minimum of 5 years in Clinical Research in Clinical Research Organization (CRO) or pharmaceutical industry, with at least 3 years in Oncology drug development; experience in Immuno-Oncology is preferred.
Significant experience with review and analysis of clinical trial data, exploration, analysis, and presentation software.
Proficient knowledge of GCP/ICH, drug development process, clinical study design, statistics, and clinical operations.

Why us?

Working in an innovative and dynamic environment and being part of a thriving biotech company.
Great working atmosphere within a highly motivated and multicultural team.
Creative working in cross-functional teams.
Short communication channels.
Hybrid working environment, with the expectation of being in the office once per week.

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!

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CatalYm GmbH

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