About us
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!
Clinical Trial Associate (f/m/d)
Festanstellung, Vollzeit · Planegg-Martinsried
Support of the planning, implementation and management of CatalYm’s clinical trial(s) mainly conducted in the field of immune-oncology.
Work with and support of the CRO team in compilation and submission of packages for clinical trial application to Health Authorities and Ethics Committees/Institutional Review Boards.
Support of the Clinical Team in all aspects of the organization and management of clinical trials according to ICH-GCP, applicable regulations and SOPs.
Set up and maintenance of clinical trial insurance in participating countries.
Support of the Trial Team in generating, updating and reviewing trial related documents and manuals.
Support in set-up of trial processes and all administrative tasks in the context of clinical trials.
Accurately monitor, update and maintain trial status and overview lists.
Track status of trial-related tasks.
Support trial-related invoicing / budgeting and contract management for the Clinical Department.
Set-up, maintain and review Trial Master File including supporting quality control of documents.
Correspond with internal and external partners and support management of vendors.
Support the Head/Director CO in definition and development of internal processes, e.g., SOP writing.
Preparation and participation in the Investigator Meeting.
Bachelor's or Master's degree in Life Sciences or equivalent with 3+ years of experience as a Clinical Trial. Associate in a biotech, pharma or CRO organisation; experience in oncology trials is an advantage.
Excellent organisational and planning skills; ability to work in a structured and accurate manner even under time pressure, experience in dealing with external parties.
Good knowledge and understanding of clinical trial processes, methodology and regulations (ICH-GCP and any local regulations).
Result-oriented approach, flexible and proactive attitude to changing needs; hands-on working style.
Excellent communication, collaboration, organisational and time management skills.
Fluent in English with excellent verbal and written skills; good level of German.
Strong computer skills (excellent knowledge of MS Excel and MS PowerPoint).
Impact & Growth - Be part of a dynamic, goal-oriented company where your contributions truly make a difference.
Innovation - Work on groundbreaking immuno-oncology therapies with a mission-driven team.
Collaboration & Culture - Enjoy a multicultural, open, and appreciative work environment and direct communication channels.
Additional Benefits - Competitive compensation, professional development opportunities, and more!
Join us in shaping the future of cancer therapy!