Clinical data manager — Define a new role in Ledidi’s Science department

Ledidi is building an in-house clinical data management service to support Medtech and IVD sponsors running clinical investigations and performance studies.

You will be the company’s dedicated clinical data manager and own the data management lifecycle in customer studies — from protocol review and database design through database lock — using Ledidi Trials and Ledidi Registries

The Clinical Data Manager should define how Ledidi, as a professional services provider, will perform data management services, including: processes, templates, SOPs, and quality standards.

Over the next two years, the function is planned to expand into broader clinical operations and compliance support, with you in a senior role.

What you will do

• Act as lead data manager on customer studies, primarily for Medtech and IVD sponsors
• Configure studies in Ledidi Trials and Ledidi Registries — eCRF design, edit checks, user roles, study workflows
• Author and maintain Data Management Plans, CRF Completion Guidelines, and data validation specifications
• Run data cleaning, query management, reconciliation, medical coding, and database lock
• Advise sponsors on study setup, data standards, and data quality
• Build out Ledidi’s data management function — SOPs, templates, quality processes
• Feed product improvements back to the Ledidi product and development teams from hands-on study experience
• Train and support investigators and sponsors on Ledidi Trials and Ledidi Registries

Required qualifications

• Bachelor’s or master’s degree in health sciences, life sciences, biostatistics, epidemiology, bioinformatics or equivalent
• Minimum 2–3 years of experience as a clinical data manager from a CRO, sponsor or academic research unit
• Current GCP certification (ICH E6 R2 or R3)
• Working knowledge of MDR (EU 2017/745) and ISO 14155, and/or IVDR (EU 2017/746) and ISO 20916
• Hands-on experience with at least one EDC system (e.g. Medidata Rave, Veeva Vault CDMS, Viedoc, REDCap, Castor, OpenClinica) — preferably including study build, not only data entry
• Understanding of GDPR and FDA 21 CFR Part 11
• Fluent written and oral English

Desirable qualifications

• PhD or other research experience
• Working knowledge of Norwegian
• Knowledge of CDISC standards (CDASH, SDTM) and medical coding (MedDRA, WHODrug)
• Experience with PMCF studies and IVD clinical performance studies
• Experience with statistical software (R, SPSS, SAS or Stata) and SQL
• Exposure to clinical QA or regulatory affairs
• Experience with risk-based and remote monitoring

Who you are

• Detail-oriented, structured, and quality-driven
• Self-driven and motivated team player
• Strong communicator and thrives with customer interaction
• Motivated by the chance to shape a new position

Practical information

• Location: Oslo Science Park.
• Primarily on-site work, with home office flexibly arranged upon agreement
• Travel: low — occasional national and international visits to sponsors and sites, but not a core requirement of the role
• Salary: competitive salary and participation in Ledidi’s Long Term Incentive Program
• Reports to: Chief Science Officer
• Start date: as soon as possible

For an informal conversation about the role, contact Chief Science Officer Ivar Sjaastad at ivar.sjaastad@ledidi.no or +47 907 92 893.

Send your CV and a short motivation letter to the same address by 24.06.2026.

Read more about Ledidi at www.ledidi.com or on our LinkedIn page.

Ledidi is a Norwegian SaaS company developing Ledidi Trials and Ledidi Registries — software used by (clinical) researchers, companies, and sponsors to run clinical trials and clinical quality registries.

The platforms enable real-time collaboration across institutions and countries, and replace the fragmented spreadsheet-and-email workflow that still dominates clinical research.

Ledidi has customers across the globe, mainly in Europe and the United States.

Our software is used by more than 150 NHS hospitals in the UK, and by major Norwegian institutions including Oslo University Hospital and St. Olavs Hospital.