Clinical Operations Coordinator

The Position
Drive Excellence in Early Clinical Development with Passion and Precision

Join us as a Clinical Operations Coordinator (COC) and play a key role in shaping the future of Clinical Operations (ClinOps) within Experimental Medicine. In this position you will manage the operational services 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 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. Contact us to learn more about this opportunity in the job and for your personal professional development.

This position has a hybrid setup with approximately 2-3 days per week on site.

Tasks & responsibilities

• In your new role, you will own the oversight of all operational aspects of early clinical trials throughout the lifecycle, including planning, conducting, analyzing, and reporting. 
• Together with the CTL you will design and manage trial set-up and plan efficient and compliant trial conduct 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 procedures at the trial site and provide professional guidance to the team throughout the entire study duration.
• You will ensure regulatory compliance by preparing study-related documents like submission documents and co-developing submission strategies, while also conducting on-site audits in close collaboration with Global Sourcing, Quality Management, CTLs, and CTMs, to meet study-specific and regulatory requirements.
• Furthermore, you will proactively follow up with internal and external business partners to ensure timelines are met, while communicating potential conflicts and proactive solutions in a timely manner.
• As an interface to Quality Vendor Compliance and CROs you will ensure that clinical studies are compliant, from recruitment through to timeline adherence and report any non-compliances.
• You will manage knowledge sharing and report CAPAs as organizational learnings, while also overseeing the trial budget and coordinating cost management from purchase orders to invoice processing.

Requirements

• University degree in natural sciences or comparable qualification with long-term professional experience in clinical trial management, CTM, CRA or similar roles in clinical development in the pharmaceutical industry in an international context 
• Solid knowledge of the pharmaceutical industry and clinical drug development, with a strong understanding of scientific and operational aspects of early clinical trials as well as 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 decisions 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
• 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 October 22nd, 2025
Step 2: Virtual meeting end of October
Step 3: On-site interviews mid of November