Clinical Trial Manager – Early Phase (m/f/d)- ITM Isotope Technologies Munich SE

ITM Isotope Technologies Munich SE; Garching bei München; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading biotechnology firm in Garching bei München is seeking a Clinical Trial Manager to oversee early-phase clinical trials in oncology. The ideal candidate will have extensive clinical research experience, strong leadership skills, and knowledge of ICH-GCP regulations. This role offers flexible working arrangements, an innovative workplace, and comprehensive benefits including training programs and health initiatives.

Leistungen

Flexible working hours

Employee participation programme

Above-average pension contribution

Health promotion programs

Qualifikationen

• Several years of experience in managing global clinical trials, preferably in oncology.
• Deep understanding of regulatory frameworks like ICH-GCP and FDA guidelines.
• Ability to work independently and collaboratively in a team environment.

Aufgaben

• Ensure compliance with GCP and manage trial recruitment across countries.
• Coordinate trial timelines and resource planning for on-time execution.
• Lead creation and approval of essential trial documents.

Kenntnisse

Clinical research experience

Leadership skills

Problem-solving abilities

Communication skills

Knowledge of ICH-GCP

Fluency in English

Ausbildung

University degree in Life Science, Chemistry, Biology or Pharmacy

Tools

Clinical trial management systems

eTMF

Jobbeschreibung

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)