Senior Clinical Operations Coordinator

vor 1 Tag

Allschwil, Schweiz Flexsis Schweiz Vollzeit

Senior Clinical Operations Coordinator (m/f/d) An internationally operating healthcare company focused on quality, broad access to medicines and sustainable development is seeking a Senior Clinical Operations Coordinator (m/f/d) to join its global Clinical Operations team. This role offers the opportunity to make a meaningful impact on global health while working in a collaborative, forward-thinking environment that values courage, responsibility, and personal growth. Your Responsibilities – How You Will Make an Impact Study Planning & Operational Support Provide comprehensive operational and administrative support throughout all phases of assigned clinical trials (set-up, conduct, close-out, archiving) Coordinate key trial activities such as site initiations and closures, eTMF management, contracts, invoices, import/export licenses, and submissions to authorities and ethics committees Support monitoring progress on eCRF completion, SDV activities, and query resolution timelines Collaboration with CROs & External Service Providers Assist the Clinical Operations Manager in overseeing CROs and external service providers Contribute to the development of specifications, testing, and implementation for study-related services Take responsibility for selected vendor management activities during trial conduct Support review and processing of invoices for CROs and other vendors, ensuring alignment with the agreed scope of work Documentation & Quality Management Develop trial‑specific tools and related documentation Review essential study documents required for initial IMP release to sites Ensure accurate set‑up, maintenance, quality control and timely archiving of the eTMF Act as Study Owner in the eTMF when required Regulatory & Operational Coordination Prepare and coordinate submission packages for health authorities and ethics committees Respond to study‑related questions from CRAs Prepare, support and follow up on internal and external audits and inspections Contribute to CAPA activities and general process improvement initiatives Team & Cross‑functional Collaboration Train, mentor and support new team members Assist in reviewing and providing feedback on SOPs, Work Instructions and processes Act as delegate for other Clinical Operations Coordinators or Managers when needed, and be deputized by others as per internal guidelines Your Profile – What You Bring Professional Qualifications Bachelor’s degree in life sciences, healthcare, or related field (or comparable relevant experience) Minimum of 3 years of experience in clinical research Solid understanding of ICH‑GCP guidelines Hands‑on experience with eTMF and CTMS Proficiency with MS Office applications (Word, Excel, PowerPoint) Strong written and verbal communication skills in English Ability to work independently and manage multiple priorities in a fast‑paced environment Problem‑solving mindset and ability to find effective solutions Willingness to travel occasionally (

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