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Senior Clinical Research Associate
vor 2 Wochen
**Overview**:
We are currently seeking a full-time **Senior Clinical Research Associate* **to support our Clinical Operations team. The position can be located in Tübingen, Munich or home-based (Germany).
**Your mission**:
The primary responsibility of this position is to ensure clinical trial site management and monitoring activities in compliance with GCP guidelines, national and local regulations or laws, and SOPs, including but not limited to:
- Support clinical trial site feasibility and site selection process
- Conduct all aspects of clinical monitoring for clinical trials including conduct of site qualification visits, site initiation visits, routine monitoring visits and close-out visits at clinical trial sites
- Support the maintenance of the Investigator Site Files and Trial Master Files
- Conduct all aspects of site management as prescribed in the clinical trial specific functional plans
- Prepare accurate and timely trip visit reports
- Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiate appropriate actions to achieve objectives
- Contribute to the development of Case Report Forms and clinical trial documents
- Act as primary contact for clinical trial supplies and other suppliers (vendors)
- Participate in regular clinical trial team meetings
- Proactively contribute to continuous improvement of Clinical Operation specific processes, procedures and templates
**Your profile**:
- Minimum of Bachelor’s Degree, preferably in life science or nursing, or equivalent
- At least 3 years of on-site monitoring experience in the pharmaceutical/ biotechnology industry (incl. all monitoring visit types)
- In-depth knowledge of ICH-GCP and applicable local regulations and laws
- Understanding of basic medical oncology terminology and science preferable
- Advanced verbal and written communication in German and English
- Good presentation and organizational skills
- Ability to develop and implement solutions within own area of responsibility
- Advanced time management to work efficiently within the budget and scope
- Advanced attention to detail while bringing a deep understanding of priorities within own scope with limited supervision
- Contributing to Company standards, global harmonization and innovation in own scope
- Positive attitude and willingness to learn and contribute to a team
- Sound computer skills including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS, EDC, IRT)
- Willingness to travel up to 75%
**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 employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits - 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.
**About us**:
