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Clinical Trial Manager* at Immatics

extra holidays - extra parental leave

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Germany

Offer summary

Qualifications:

Bachelor's degree in life science or nursing, 4+ years experience in clinical monitoring.

Key responsabilities:

Ensure site management in compliance with guidelines and regulations
Drive site initiation and greenlight process
Contribute to training, review progress of trials
Manage protocol deviations, oversee CRA performance
Contribute to continuous improvement

Immatics Biotech: Biology + Technology SME https://www.immatics.com/

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Job description

Overview

We are currently seeking a Clinical Trial Manager*Â (32-40 hours/week) to strengthen our Clinical Operations department. You will work in TÃ¼bingen/ Munich/ home-based in Germany in an interdisciplinary global environment with colleagues from Germany and Houston (TX). Your clinical monitoring experience and action-oriented working style will contribute to our teamâs success.

Your mission

Your main responsibilities will include the following tasks:

Ensure clinical trial site management and monitoring activities in compliance with GCP guidelines, national and local regulations or laws, and SOPs for assigned clinical trials
Clinical trial site feasibility and selection
Create, maintain and implement trial-specific plans, tools and documents required per SOP (e.g., training material, annotated trip reports, Clinical Monitoring Plan, Deviation Handling Plan)
Oversee or perform collection of clinical trial site specific documents ensuring on time regulatory submissions (CA, IRB/IEC) according to local requirements
Driving the clinical site initiation and greenlight process according to project goals
Actively contribute to clinical trial site management and engagement to establish and maintain close site relationships
Organize and oversee project-specific training for CRAs and clinical trial sites
Review trip reports and provide day-to-day expert advice to CRAs
Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiate appropriate actions to achieve objectives
Conduct Monitoring Oversight Visits ensuring clinical trial site and internal/external CRA performance
Manage protocol deviations according to SOP
Proactively contributes to continuous improvement of Clinical Operation specific processes, procedure and templates

Your profile

You hold a Bachelorâs degree preferably in life science or nursing, or equivalent. You bring at least 4 years of on-site monitoring experience in the pharmaceutical/ biotechnology industry (incl. all monitoring visit types), and a comprehensive knowledge of ICH-GCP, FDA and EMA guidelines and applicable local regulations. You have already gained significant insights into clinical trial management activities. Knowledge of basic medical oncology terminology and cell therapy is an advantage.Â

We expect a high degree of independent working, analytical thinking and excellent communication skills in German and English. You are a good team player and role model with very good organization, negotiation and resolution skills. Travelling up to 30% is acceptable for you. You embrace rapidly changing requirements with an open mind, think outside the box and show a high degree of flexibility in an environment which is marked by a constant striving for excellence. Your motivation is driven by excellence, efficiency and joy at work. You approach tasks in a structured, reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills.

Why us?

We are a committed and inspired team and cherish the collegial, highly motivated, and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employeesâ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits â e.g., job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.

Notice

*We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

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About us

Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. Operating from Tuebingen, Munich and Houston, we are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. For more detailed information, visit www.immatics.com.