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 remote-based or hybrid working model in Garching as soon as possible
Senior Clinical Trial Manager, China (f/m/d)
Your role
- Overseeing that all clinical trials conducted in China within a particular product’s development are managed to ensure proper clinical trial performance in accordance with GCP, internal SOPs and other applicable regulations
- Ensuring that coordination and control of the clinical trials' timelines are maintained, either directly or by overseeing appropriately qualified CTMs, to ensure on-time clinical trial conduct
- Assuring standard processes and procedures are established across all studies within therapeutic area, to provide full time quality review and assessment of clinical trials performance
- Supporting the VP, Head of Global Clinical Operations / Director of Clinical Operations and HoF, to ensure that contractual agreed KPIs and timelines with CROs, Partner Companies and vendors are met, implements corrective measures as needed and escalates underperformance, if required
- Acting as Escalation point to the Clinical Team
- Development / Co-development, review and approval of clinical trial documentation (Study protocols and amendments, IB, Patient consent forms, case report forms, clinical trial manuals and clinical trial tools)
- Management and oversight of multidisciplinary clinical trial teams
- Preparation of and participation in Scientific Advice Meetings with Health Authorities
- CRO / Vendor coordination and oversight
- Participate in the ongoing and final review of study data and assessment of the impact of the data to the clinical development program
- Develop supportive tools to aid in the logistics of the trial management and other processes, such as SOPs
Your profile
- Successfully completed your scientific degree
- Several years of professional experience in global clinical research and the management of (international) clinical trials, as well as Chinese clinical research trials
- Knowledge of FDA, EMA and ICH / GCP regulations and guidelines, as well as China specific regulations and requirements
- Experience in the delegation, mentoring and supervision of clinical trial management responsibilities within China and elsewhere
- Experience in coordination of clinical teams, with both internal and external members
- Ability to pay attention to details and initiate actions independently
- Solid background in oncology and interest in new therapies
- Strong communication skills
- Independent, proactive, and goal-oriented work style
- Fluency in English and Chinese (Cantonese and Mandarin) language
- Willingsness for international travel
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
- Individually tailored further training programme (including German and English courses)
- Health promotion programmes
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 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
