Adresse
Form der ArbeitAbout ITM
ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).
Your Role:
- Support Quality Assurance activities to ensure GCP and other regulatory requirements are met including but not limited to
- Assist in deviation management including CAPA management and follow-up
- Assist in audit management activities (internal, investigator site, vendor)
- Support GCP sponsor inspections by regulatory authorities
- Work collaboratively with other GxP QA personnel and cross-functionally to assist in maintaining a fit-for-purpose, compliant, and fully integrated ITM QMS
- Support the provision of GCP training
- Prepare data and metrics supporting ITM Quality Management Reviews
- Support cross-functional teams to establish and maintain processes in the Clinical Development & Clinical Operations departments
- Support the organization by gathering the most up to date regulatory intelligence related to clinical trials and observational studies
What we are looking for:
- Undergraduate degree (Bachelor) or comparable education in nursing, life sciences or similar
- 2-5+ years of relevant experience in clinical operations, CRO experience preferred
- Experience with electronic Trial Master File and electronic Document Management System
- Excellent verbal and written communication skills in English (German would be an asset)
- Detail oriented but pragmatic
- Service + solution oriented
- Quality mindset
- Strong interpersonal relationship and collaboration skills working within cross-functional teams
- Organized, self-directed and efficiency-minded working style
- Flexible with changing priorities and able to work in a consistently changing environment
What we offer:
- A modern workplace and exciting opportunities in an evolving and fast growing company
- Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
- A collegial corporate culture and short communication channels
- Flexible working hours with an attractive salary package and diverse corporate benefits
Contact for your application:
ITM Isotope Technologies Munich SE
Human Resources
Walther-von-Dyck-Str. 4
85748 Garching/Munich, Germany
E-Mail: career@itm-radiopharma.com
Phone: +49 089 329 8986 1709
Contact: Nadine Suerken
For more information please visit: www.itm-radiopharma.com
