Ingelheim, DEU
21 hours ago
Clinical Operations Manager - CO Strategy & Operations, Experimental Medicine
**The Position** **Drive Excellence in Early Clinical Development with Passion and Precision** Join us in the role as a Clinical Operations Manager (COM) and be an active contributor to Clinical Operations (ClinOps) at Experimental Medicine. In this position, you will manage the operational services as well as the Monitoring oversight to deliver early clinical trials until Proof of Concept in healthy volunteers and in patients in a smooth, timely and compliant manner. In a team of three with the Clinical Trial Leader (CTL) and the Clinical Trial Coordinator (CTC) you will manage trial set-up, conduct and closing with oversight on timelines, costs and quality. You will be part of a passionate, agile, and innovative team of COCs (Clinical Operations Coordinators) and COMs where your ideas and engagement are valued, and where you’ll contribute to exploring new opportunities to make Clinical Operations at Experimental Medicine successful with our patients in mind. **Ready to make an impact? Apply now and discover how this role can advance both our mission and your career.** This position can be filled in Ingelheim or Biberach. This position has a hybrid setup with approximately 2-3 days per week on site. **Tasks & responsibilities** + In your role as COM, you will own the oversight of all operational aspects of early clinical trials throughout the lifecycle, i.e. planning, conduct, analysis, and reporting. This also involves the trial budget and coordinating the trial cost management from Purchase Order to invoices. + Furthermore, together with the CTL you will design and manage trial set-up and plan efficient and compliant trial conduct and monitoring oversight in healthy volunteers and patient studies. + As a member of the Trial Core Team, you will work closely with the CTL and the CTC, and liaise with external business partners, i.e. CROs and vendors. + Moreover, you will be responsible for the conceptual planning and organization of study and monitoring procedures on a global level and provide professional guidance to the team throughout the entire study period. + You will be an active contributor for describing the process and establishing a monitoring strategy at Experimental Medicine for all trials until POC as well as creating and curating training program for the COM function. + In addition, you will ensure regulatory compliance and will be responsible for preparing relevant study documents, i.e. submission and monitoring documents, co-developing appropriate submission strategies (road to submission). + You will ensure that timelines are met by pro-actively following up with internal and external business partners as well as timely communicate and proactively resolve potential conflicts. + You will act as the interface to Quality Vendor Compliance and CROs to ensure full study compliance from recruitment to timeline adherence, including reporting of non-compliances and managing knowledge management and CAPAs learnings within the organization. + As required, you will also conduct on-site audits in close collaboration with Global Sourcing, Quality Management, CTLs, and CTMs, ensuring compliance with regulatory requirements and study-specific guidelines. **Requirements** + University degree in natural sciences or comparable qualification with significant professional experience in clinical trial management, CTM, CRA, SML or similar roles in clinical development in the pharmaceutical industry in an international context + Profound knowledge of the pharmaceutical industry and clinical drug development, with a strong understanding of scientific and operational aspects of early clinical trials + Comprehensive knowledge and long-track experience in clinical operations + In-depth knowledge and understanding of the regulatory context of clinical trials, Good Clinical Practice (GCP), other relevant regulations and internal procedures, with focus on quality compliance, legal compliance and patient safety + Demonstrated ability to drive decision for solutions, speed and innovation. + Exceptional project management, as well as communication, presentation, and negotiation skills, with sensitivity to work proven successfully in a global matrix structure + Growth mindset with a proactive approach to learning and change, empathy in collaboration, and a natural curiosity for new ideas, tools, and ways of working + Fluency in German and English + Willingness to travel where required per trial activities such as initiation visits, and internal 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 March 11th, 2026. We reserve the right to take the posting offline beforehand. Applications up to March 4th, 2026 are guaranteed to be considered. Step 2: Virtual meeting end of March Step 3: On-site interviews early to mid-April All qualified applicants will receive consideration for employment without regard to a person’s 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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