Clinical Study Manager Ivd Diagnostics Clinical Trials

**Company Description** Hello**

We're looking for an awesome Clinical Study Manager to join our team on our journey to revolutionize personalized medicine.
**Job Description** About your Role**
- Plan, execute, and close out clinical studies (domestic and international) to the highest standards of quality, ethics, and regulatory compliance.
- Build and manage collaborations with external partners and clinical site networks to expand research reach and maximize trial success.
- Lead the process for obtaining and maintaining ethical approvals; ensure compliance with international and local regulations (e.g. GDPR, HIPAA, informed consent).
- Safeguard participant privacy and data integrity across the study lifecycle, working closely with internal data experts.
- Oversee sample collection, handling, tracking, and storage, coordinating with our internal biobank for traceability and quality.
- Troubleshoot operational, logístical, and site-based issues proactively, resolving them quickly while ensuring compliance and participant safety.
- Develop and maintain study documentation and regulatory submissions, producing clear, participant-friendly materials.
- Keep stakeholders informed with regular, transparent communications on progress, risks, and milestones.
- Manage supplies and biological samples in line with evolving research requirements.

This job is based in Porto, Portugal in a hybrid working environment.
**Qualifications** Technical Skills ✔️**
- Bachelor’s or Master’s in Life Sciences, Nursing, Pharmacy, Biomedical Engineering, or related field (PharmD/PhD is a plus).
- 5+ years in Clinical Operations/Study Management (device/IVD/biotech), with 2+ years leading multi‑site studies; EU/UK experience strongly preferred.
- Solid knowledge of ICH‑GCP and ISO 14155; familiarity with IVDR (EU 2017/746) and diagnostic performance studies.
- Experience with sample logistics/biobanking (pre‑analytical handling, barcoding, chain‑of‑custody) and interfacing with central labs.
- Budgeting and site/vendor contracting; strong project management and documentation discipline.

**Cultural Skills ✔️**
- Excellent communicator who collaborates across scientific and engineering teams and can translate clinical requirements for technical and non‑technical audiences.
- Thrives in a fast‑paced start‑up; proactive, adaptable, takes ownership, and balances rigor with agility.
- Passion for innovation and a mission‑driven mindset to improve patient outcomes.

**Bonus Skills**:

- Experience with AI/ML‑enabled diagnostics or optical/spectroscopy‑based sample workflows.
- Prior exposure to performance evaluation plans, and regulatory interactions.
- Publications and established KOL/site network in neurology, oncology, or other complex disease areas.

**Additional Information**
**iLoF in a nutshell**

As personalized medicine becomes the norm, scientists, patients, and healthcare systems worldwide face massive barriers in providing the right treatment to the right patient.

Recognized by CB Insights and Financial Times as one of the most promising Digital Health companies in the world, iLoF is building an AI-powered platform capable of transforming precision medicine.

Our goal is to become the platform that democratizes access to personalized medicine for millions of people living with complex diseases around the globe.

Thanks to our proprietary optical fingerprint library of disease biomarkers and biological profiles we can offer personalized patient screening and stratification in a faster and more affordable way, saving up to 40% of the cost and 70% of the time while enabling a more human patient experience.

Supported by leading institutions like Microsoft Ventures, Mayfield, and the Oxford University, iLoF is currently focusing on validating its platform technology in one of the biggest challenges of our times: Alzheimer's, while maintaining ongoing verticals on Digestive Cancer, Stroke, and Infectious diseases.

Our Team ‍

We are a mix of scientists, entrepreneurs, and inventors based in Oxford and Porto, with a passion for healthcare

Recognized by CB Insights as one of the most promising Digital Health companies in the world and by the Financial Times as a Transformational Business in Healthcare, iLoF has been regularly featured in leading outlets like Tech Crunch, Wired, and Sifted and listed as a rising star in AI-Driven Drug Discovery, Health Screening & Data Analytics.

**What we value**
- A Be Kind attitude is the main guideline within iLoF
- A hand in the hammer and another free to support your co-workers as a true team player
- An honest and egoless attitude towards discussions and critics working in good faith
- The braveness to speak your heart in any situation
- Through words or actions be always sure to make a difference at any moment
- Be proud to drive your responsibilities to success and help others do the same, embracing ownership

**Perks**
- An exciting future with a deep-tech company selected by Fina