Clinical Study Manager | IVD | Diagnostics | Clinical Trials

Clinical Study Manager | IVD | Diagnostics | Clinical Trials
Braga
Braga, Braga, Portugal

Hello!

We're looking for an awesome Clinical Study Manager to join our team on our journey to revolutionize personalized medicine.

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, logistical, and
  - based issues proactively, resolving them quickly while ensuring compliance and participant safety.
• Develop and maintain study documentation and regulatory submissions, producing clear,
  - 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

• Bachelor’s or Master’s in Life Sciences, Nursing, Pharmacy, Biomedical Engineering, or related field (Pharm
  D/Ph
  D 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.

​​​​​​i
Lo
F 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, i
Lo
F 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, i
Lo
F 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