Hybrid role (Barcelona) | 80–100% preferred; adaptable arrangements considered

Location: Barcelona Health Hub (BHH), Recinte Modernista de Sant Pau, Barcelona, Spain

Travel: Some travel Spain and occasionally Europe

About ABCDx

ABCDx is a Swiss Spanish MedTech company developing blood-based point-of-care diagnostic solutions combining biomarkers, lateral-flow technologies, smartphone-based image analysis and clinical algorithms. Our programs focus on acute neurological and cardiovascular conditions, with clinical development activities across Spain, Switzerland and other European centres.

We’re building technology that can fundamentally change how acute conditions are assessed faster, earlier, and more objectively with real consequences for patients’ lives.

Science got us here.

The next step is turning that science into robust, regulated digital products used in clinical studies and ultimately in routine care.

This is not a role where you only maintain an existing application.

You will help build, integrate, document and own the software platform supporting multiple IVD products.

The role The Clinical Operations Manager will be responsible for the operational management of ABCDx clinical studies, from study preparation through execution, monitoring and close-out.

The position combines hands-on CRA activities with clinical project management and team coordination. The successful candidate will work closely with investigators and hospital teams, ABCDx scientists and engineers, the Geneva team, and our Head of Regulatory Affairs & Quality Assurance.

A major objective of the position will be to ensure that ABCDx clinical studies are conducted efficiently, with high-quality data and documentation, and in accordance with the company's QMS, IVDR requirements, study protocols and applicable clinical research standards.

Main responsibilities

Clinical study management

- Coordinate multicenter clinical studies for ABCDx IVD and point-of-care diagnostic products.
- Translate clinical development plans into operational study plans, timelines, milestones and site-specific activities.
- Coordinate study start-up, site activation, recruitment, monitoring and close-out.
- Track recruitment, sample collection, data completeness, protocol deviations and study milestones.
- Coordinate ethics committee and competent authority submissions and approvals in collaboration with RAQA and the study sponsor.
- Identify operational risks and implement corrective actions.

Hospital and investigator coordination

- Act as the main operational contact for participating hospitals and investigators.
- Coordinate studies performed within major grant programs, particularly sites in Spain, with possible collaborations across Europe too.
- Organize investigator meetings, site initiation visits, monitoring visits and study follow-up.
- Ensure that participating centers have the necessary protocols, kits, devices, training and documentation.




- Maintain close communication with principal investigators, study nurses, laboratory teams and hospital research units.

Clinical monitoring / CRA activities

- Perform or coordinate on-site and remote monitoring.
- Verify compliance with the protocol, informed consent requirements and study procedures.
- Review CRFs/eCRFs, source documentation and clinical databases.
- Follow data queries, missing information and protocol deviations through resolution.
- Ensure appropriate sample traceability and reconciliation between clinical data, biological samples and device/test results.
- Maintain Trial/Study Master Files and essential documentation.

QMS, IVDR and regulatory compliance

- Work closely with Head of RAQA, to ensure that clinical activities are performed within the ABCDx Quality Management System.
- Ensure appropriate application of SOPs and controlled clinical documentation.
- Contribute to clinical documentation required for IVDR performance evaluation and CE-marking activities.
- Support preparation and maintenance of clinical performance study documentation.
- Participate in CAPA, deviation, change-control and risk-management activities related to clinical studies.
- Support internal and external audits and interactions with notified bodies or regulatory authorities when required.

Internal clinical team coordination

- Coordinate the operational activities of the clinical team, including activities performed by the Geneva team.
- Establish clear responsibilities, timelines and deliverables across studies.
- Organize regular clinical project meetings and ensure systematic follow-up of actions.
- Provide management with concise dashboards covering recruitment, study status, issues, risks and next milestones.
- Work cross-functionally with R&D;, assay development, software, data science, regulatory, quality and business teams.

Grant-funded projects

- Coordinate clinical deliverables and milestones associated with Red.AI and EIT Health grants.
- Ensure that clinical activities remain aligned with grant commitments, timelines and deliverables.
- Provide the clinical information required for technical and project reporting.

Profile

We are looking for someone with:

- Degree in life sciences, biomedical sciences, medicine, pharmacy, biotechnology or a related field.
- Approximately 5+ years of experience in clinical research, preferably including CRA and clinical project-management responsibilities.
- Experience managing multicentre clinical studies and hospital sites.




- Strong experience with medical devices and/or IVD clinical studies; experience limited exclusively to pharmaceutical trials would be less relevant.
- Practical experience working within an ISO 13485 QMS or comparable regulated MedTech environment.
- Good understanding of EU IVDR 2017/746, particularly clinical performance studies and performance evaluation.
- Experience with prospective IVD clinical performance studies using human specimens is preferred.
- Experience with GCP and applicable standards for medical device/IVD clinical studies.
- Experience preparing and maintaining clinical study documentation, monitoring reports and essential files.
- Ability to coordinate several hospitals and projects simultaneously.
- Comfortable working in a small, fast-moving MedTech company where the role combines strategy with hands-on execution.

Languages

- English: fluent, essential.
- Spanish: fluent, essential.
- Catalan: highly desirable.
- French would be an advantage for interaction with the Geneva team.

Personal profile

We are looking for someone who is organized, pragmatic and capable of taking ownership. The person should be equally comfortable discussing a study with a principal investigator, reviewing a CRF with a study coordinator, resolving an operational issue at a hospital and working with RAQA to ensure that the documentation meets IVDR and QMS requirements.

Benefits

- See the direct impact of your work internally and in the real world.
- Work in a purpose-driven, self-managed startup with real autonomy.
- Join a team that values honesty, curiosity, and collaboration over hierarchy.
- Have the freedom to experiment, learn, and innovate without fear of failure.
- The opportunity to build the software foundation of a scaling MedTech startup. Work in a beautiful office in a UNESCO World Heritage site in Barcelona, with one of the best rooftop views in the city, combined with flexibility for remote work and versátil scheduling.

What It’s Like to Work at ABCDx

- You belong to a team, not a hierarchy. We believe in hiring for strengths and complementing weaknesses. No one is great at everything, and that’s okay—we build teams that lift each other up. Expect honest feedback, open discussions, and collaboration without ego. We challenge each other’s ideas because that’s how we grow.
- You own your decisions. No micromanagement, no clock-watching — just freedom, responsibility, and accountability for outcomes that matter. You’re responsible for driving your work forward.
- You’re encouraged to be bold. We experiment, learn fast, and improve constantly. Trying, failing, and iterating are part of building something meaningful.
- You can be yourself. No politics, no masks. Just real people, real conversations, and a shared drive to build something we’re proud of. We value self-awareness. If you can talk about your strengths and weaknesses honestly, you’ll fit right in.

📌 Clinical Operations Coordinator / Senior CRA – IVD & MedTech (Barcelona)
🏢 ABCDx
📍 Barcelona