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 (<10%)
Personal Skills
* Excellent organizational and time management skills
* Ability to work effectively under pressure
* Strong attention to detail and quality orientation
* Team player with a proactive, results‑driven attitude
* Ability to train and mentor other team members
Seniority level
Associate
Employment type
Full‑time
Job function
Other
Industries
Pharmaceutical Manufacturing
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