Clinical Operations Lead, Cardiac Device Trials

Acorai is a Swedish medtech company developing the SAVE Sensor System, a non‐invasive handheld device that estimates cardiac filling pressures in patients with heart failure.
SAVE combines synchronised ECG, photoplethysmography, heart sounds and cardiac vibrations with machine learning.
The aim is to give clinicians information that today requires an invasive right‐heart catheterisation.
We run multicentre clinical investigations across Europe, the US and Asia.
This role is based in Portugal and works as part of our international clinical team.
The role
We're looking for a hands‐on clinical research professional to help run the clinical investigations that validate our technology.
You'll sit between our sites and our data.
You'll make sure studies run to protocol, that every device recording and reference measurement is complete and usable, and that the resulting evidence is documented to regulatory standard.
It's a broad role in a small team, suited to someone who wants ownership and variety.
What you'll do
Clinical investigation data Help design and maintain eCRFs, data management plans and edit checks in our EDC system Run ongoing central data review: query management, missing‐data follow‐up, and reconciliation of device signal recordings against eCRF and right‐heart catheterisation reference data Monitor recording quality and data flow from sites, and resolve data issues with sites and our engineering team Prepare datasets for analysis and support database lock Site monitoring and management Conduct site initiation, monitoring and close‐out visits, both on site and remotely Perform source data verification, and review investigator site files, informed consent, device accountability and protocol compliance Train site staff on the protocol, device use and data capture Track and follow up deviations, adverse events and device deficiencies Study documentation Help draft and maintain clinical investigation plans, monitoring plans, informed consent forms and study reports Prepare ethics committee and IRB submissions and amendments, and contribute clinical data and documentation to regulatory submissions Maintain an inspection‐ready Trial Master File Keep R&D project documentation and progress reporting up to date What you bring
A degree (licenciatura or higher) in life sciences, nursing, biomedical engineering or a related field 3+ years in clinical research, for example as a CRA, study nurse/coordinator or clinical data manager Working knowledge of ISO * and ICH GCP Hands‐on experience with EDC systems (e.G. Viedoc, REDCap, Medidata Rave) Precision, a structured way of working, and comfort operating independently Fluent written and spoken English Based in Portugal (or willing to relocate) and eligible to work there Willingness to travel internationally (approx. *%) Nice to have Cardiology experience, especially heart failure or the cath lab Medical device clinical investigations under EU MDR, or FDA IDE studies Familiarity with physiological signal data, or data skills in R, Python or SQL What we offer
A central role in taking a novel cardiac device through clinical validation to market Direct work with leading clinicians and international sites, and with our team in Sweden A small, ambitious team where your work visibly shapes the outcome Clinical Operations Specialist Lisbon, Portuguese Republic, PT