Global Clinical Trial Manager

Acorai; Portugal; Híbrido; EUR 70 000 - 110 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid working in Portugal

Competitive salary

Employee option programme

Direct line to CEO

Resumo da oferta

Acorai seeks a Global Clinical Trial Manager to own and run the company’s clinical studies, starting with the US validation programme and expanding to interventional outcomes studies. You will collaborate directly with the CEO, QA/RA and regulatory partners, with a small team and strong ownership as the programme scales.

You will manage startup activities, day-to-day monitoring, and FDA submission support, while building the forward programme and ensuring TMF readiness.

Qualificações

• 5+ years in clinical operations with US study experience
• Experience with medical device trials (ISO 14155, 21 CFR 812)
• Hands-on monitoring experience including SIVs
• Willingness to travel internationally (~25–30%)
• Fluent English; based in Portugal or willing to relocate

Responsabilidades

• Start up US sites end to end: feasibility, CTA, budget, IRB, activation
• Manage day-to-day studies: monitoring, SDV, queries, enrolment
• Draft clinical docs to ISO 14155, 21 CFR 812, ICH-GCP
• Prepare content for FDA submissions and pre-submission support
• Select/manage CROs, labs, and vendors; in-house when faster
• Own study data quality end to end with data/algorithm teams
• Build future interventional and health economic studies and strategy
• Maintain TMF and stay inspection-ready

Conhecimentos

Clinical operations

US site startup

Monitoring

Regulatory knowledge

Travel readiness

Fluent English

Descrição da oferta de emprego

Acorai is a Swedish medtech company building the SAVE Sensor System — a non-invasive, handheld device that estimates intracardiac filling pressures at the bedside. Today the only reliable way to measure those pressures is right heart catheterisation: invasive, expensive, and confined to a cath lab. We are replacing it with a short bedside recording.

Heart failure is one of the largest drivers of hospitalisation and readmission in the world, and most of those readmissions are congestion. If a clinician can see filling pressure non-invasively, congestion can be treated before it becomes an admission. That is the problem we are solving.

We are preparing our US regulatory submission and building the global clinical programme behind it. We are hiring a Global Clinical Trial Manager to run it.

THE ROLE

Hands-on and end-to-end. You will own the execution of our clinical studies — starting with the US validation programme — and then build the programme that comes after it: interventional outcomes studies and health economic evidence.

You will work directly with the CEO, our QA/RA and regulatory partners, and our investigators. Small team, no layers, and genuine ownership of a programme at the moment it scales from a handful of studies into a full evidence package.

WHAT YOU WILL DO

• Start up US sites end to end — feasibility, site selection, CTA and budget negotiation, IRB submissions, essential documents, site initiation visits, activation
• Run studies day to day: on-site and remote monitoring, source data verification, query management, deviation handling, enrolment and site performance tracking
• Draft and maintain clinical documentation — protocols/CIPs, ICFs, monitoring plans, CRFs, study reports — to ISO 14155, 21 CFR 812 and ICH-GCP
• Prepare clinical content for FDA submissions and support pre-submission interactions and responses
• Select and manage CROs, central labs, adjudication committees and other vendors — and run work in-house where that is faster and better
• Own study data quality end to end, working closely with our data and algorithm teams
• Build the forward programme: design, cost and operationalise future interventional and health economic studies, and shape clinical strategy with the executive team
• Maintain the TMF and keep the programme inspection-ready

WHAT YOU BRING

• 5+ years in clinical operations, with substantial time running US studies — you have started up US sites yourself and know how US contracting, IRB submissions and site management actually work
• Medical device trial experience (ISO 14155, 21 CFR 812, IDE/NSR determinations); cardiovascular or diagnostics a strong plus
• Real monitoring experience — you have run SIVs and monitoring visits personally, not only overseen a CRO doing them
• Willingness to travel internationally, primarily to US sites (~25–30%)
• Fluent English; based in Portugal or willing to relocate
• Startup temperament: comfortable owning outcomes with limited infrastructure, building process where none exists, and moving between clinical strategy and hands-on execution in the same day

NICE TO HAVE

• Contributed to the clinical sections of an FDA 510(k), De Novo or PMA
• Heart failure or haemodynamics background
• Health economic or outcomes research experience
• Experience with AI/ML-enabled device validation (blinding, locked algorithms, out-of-sample validation)
• EU MDR and national competent authority submission experience

WHAT WE OFFER

• Ownership of a global clinical programme, not a slice of one
• A direct line to the CEO and to regulatory strategy — your work goes straight into FDA submissions and reimbursement dossiers
• Hybrid working in Portugal, in a team spread across Sweden, Portugal and the US
• Competitive salary and participation in our employee option programme
• A device that has the potential to transform how heart failure is managed for millions of patients around the world.