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Clinical trial coordinator

Ingelheim am Rhein
Boehringer Ingelheim
Coordinator
Inserat online seit: 23 Oktober
Beschreibung

The Position Drive Execution Excellence in Early Clinical Development with Passion and Precision Join us as Clinical Trial Coordinator (CTC) and be an active contributor to Clinical Operations (ClinOps) at Experimental Medicine. As a key member of the dynamic and collaborative trial core team, youu2019ll work in close collaboration with the Clinical Trial Leader (CTL) and Clinical Operations Coordinator (COC) to provide essential operational and administrative trial services, securing smooth trial planning and conduct throughout early phases of clinical trials up to Proof of Concept in healthy volunteers and patients. You will be part of a passionate, agile, and innovative team of CTCs where your ideas and engagement are valued, and where youu2019ll contribute to exploring new opportunities to make Clinical Operations at Experimental Medicine successful with our patients in mind. Ready to make a difference? Apply now and be part of something extraordinary. This position has a hybrid setup with approximately 2 to 3 days per week on site. Tasks & responsibilities In your new role, you will oversee the global planning, execution, and closure of clinical trials in close collaboration with the extended trial team such as regulatory affairs, local study leads, IMP supply, and other key stakeholders. Moreover, you will proactively follow up with internal and external stakeholders to ensure timelines are met as well as communicate potential conflicts and issues early to enable timely resolution. As CTC you will coordinate and execute general administrative tasks in clinical trials, such as requesting of the extended trial team assignments, organizing trial team meetings including meeting minutes, handling of and contribution to essential trial documents as well as system account management of internal and external team members. Furthermore, you will ensure timely input of relevant data and information in clinical trial systems such as Veeva (OMP and RIM), Clinergize, and Site Connect as well as oversee study close-out activities, including CTR Appendix compilation and TMF completeness checks. You will take ownership of regulatory-compliant documentation, including the Investigator Site File and Trial Master File, in alignment with ICH-GCP, other relevant regulations and internal procedures. Additionally, collaborating closely with Regulatory Affairs and local leads, you will support EU trial submissions by preparing complete and timely packages, especially focusing on country-specific Part II documents. For trials conducted in Germany you will act as the primary contact for our external trial sites regarding the collection of submission documents, managing trial related system access and essential trial document distribution, always ensuring a good collaboration with the site from start-up to close-out. Requirements University degree in natural sciences or equivalent qualification with long-term relevant professional experience in the pharmaceutical industry or clinical organizations Solid understanding of clinical development in the pharmaceutical industry as well as solid knowledge of clinical trial management throughout the clinical trial lifecycle, from planning, over conduct to close-out activities, incl. document landscape (ISF, TMF, etc.) Excellent knowledge of GCP, other regulatory requirements and quality compliance in the fields of early clinical trials and proficiency in MS Office, Clinical Trial Management Systems and ability to quickly learn new tools Excellent organizational skills and attention to detail, with a high degree in commitment to quality and timelines as well as strong communication skills for working in a global environment and with various internal and external business interfaces Outcome-driven thinking paired with a high degree of collaborative, integrative mindset to work with empathy and pragmatism in a team and a growth mindset with a proactive approach to learn and a natural curiosity for new ideas, tools, and ways of working Fluency in English Willingness to travel where required per trial activities such as initiation visits, or 3 to 4 times/year for group and team meetings as required Ready to contact us? If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: 49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com Recruitment process: Step 1: Online application - The job posting is presumably online until November 3rd, 2025 Step 2: Virtual meeting starting mid of November 2025 Step 3: On-site interviews at end of November 2025 All qualified applicants will receive consideration for employment without regard to a personu2019s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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Home > Stellenangebote > Logistik Jobs > Coordinator Jobs > Coordinator Jobs im Kreis Mainz-Bingen > Clinical Trial Coordinator

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