Clinical data manager
LEDIDI AS
Frist Snarest
Ansettelsesform Fast
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 through the link by 24\.06\.2026\.
Read more about Ledidi at www.ledidi.com or on our LinkedIn page.
Ferdigheter
General Data Protection Regulation (GDPR)
Good Clinical Practice (GCP)
Helsevitenskap
SOP
Utføre datarensing
Om arbeidsgiveren
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.
Sektor: Privat
Sted: Gaustadalléen 21, 0349 Oslo
Hjemmekontor: Delvis hjemmekontor
Bransje: Forskning, utdanning og vitenskap, Helse og omsorg, IT \- programvare
Stillingsfunksjon: Analyse, Data Scientist, Rådgivning
Arbeidsspråk: Engelsk, Norsk
Nøkkelord
klinisk databehandling, datamanager, medisinsk teknologi, ivd, studiedesign
Spørsmål om stillingen
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- Kontaktperson: Ivar Sjaastad
- Stillingstittel: Chief Science Officer
- Mobil: 90 79 28 93
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