About 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).
We would like to fill the following permanent vacancy in a hybrid working model in Garching as soon as possible
Clinical Trial Manager - Early Phase (f/m/d)
Your role
- Clinical Trial Oversight and Management: Ensure compliance with GCP, SOPs, and regulations, manage recruitment across countries, and collaborate with LCRA to align the monitoring team with trial needs
- Timeline and Resource Planning: Coordinate trial timelines with the CTL, plan resources like Veeva eTMF and co-monitoring, and ensure on-time trial execution and activity completion
- CRO and Vendor Management: Oversee and evaluate CRO and service provider performance using KPIs, collaborate with the Vendor Management team, and assist in vendor selection and management
- Document and Risk Management: Lead the creation and approval of essential trial documents, manage risk identification and mitigation, and track audit findings and CAPAs
- Data Review and Reporting: Participate in ongoing and final data reviews, reporting issues or trends to the CTL
- Team Leadership and Communication: Lead team meetings, provide training and mentorship to junior CRAs and new team members, and ensure effective communication between the sponsor, CRO, and other stakeholders
Your profile
- A university degree - preferably in Life Science, Chemistry, Biology or Pharmacy
- Several years of proven professional experience in clinical research and the management of global clinical trials, with a strong emphasis on multinational oncology studies
- Deep understanding and sound knowledge of ICH-GCP, FDA, EMA, and other relevant regulatory frameworks and guidelines
- Solid background in oncology and a strong interest in new therapies
- Proficiency with clinical trial management systems (CTMS), EDC, IRT systems, and eTMF
- Strong communication and leadership skills, including experience managing CRO relationships
- Excellent problem-solving abilities and a proactive approach to risk management
- Ability to work independently within agreed goals and in a cross-functional team environment, providing constructive feedback
- An independent, communicative, proactive, goal-oriented, and reliable work approach
- Fluency in English
- Willingness to travel internationally
Our offer
- Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom
- An open working atmosphere in an international corporate culture with short communication channels
- Comprehensive onboarding programme
- Flexible working hours with home office options
- Attractive special payments
- Just a good salary? Not with us! We also offer you Employee participation programme
- Job bike or subsidised job ticket
- Above-average contribution to the company pension scheme
- Individually tailored further training programme (including German and English courses)
- Health promotion programmes (e.g. EGYM Wellpass, subsidy for local fitness studio, sponsorship of sporting events, various lifestyle coaching sessions)
Do you have these qualifications, are you willing to develop yourself further and are you looking forward to becoming a key part of our future? Great! We should get to know each other!
When you apply, please let us know your earliest possible starting date and your salary expectations. You can submit your CV in German and English in docx or pdf format.
Contact
Nadine Sürken
+49 89 329 8986 -1709
career@itm-radiopharma.com
ITM Isotope Technologies Munich SE
Human Resources
Walther-von-Dyck-Str. 4
85748 Garching/München, Deutschland
Note for recruitment agencies
Please note that we do not accept unsolicited applications or offers of assistance. The telephone number given in the advertisement is intended exclusively for applicants and should not be contacted for any other purpose. Thank you very much!
More about ITM
With us, you will have the opportunity to work in an international environment on ground-breaking projects that can have a significant impact on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who share our vision and want to help shape the future of oncology. If this exciting challenge appeals to you and you would like to contribute to realising our common goal, please do not hesitate to send us your application. We look forward to hearing from you!
For more information please visit: www.itm-radiopharma.com
