Senior Clinical Data Manager - RWE Remote

Clinical Data Manager
- Real-World Evidence
- Observational and Disease Registry studies

Location: UK / Remote

Permanent

** MUST HAVE RWE and registry or observational study experience**

KEMIO is looking for an experienced Clinical Data Manager to join a growing Healthcare and Data Analytics Life Sciences organisation delivering observational clinical studies and real-world evidence programmes
, with a particular focus on oncology and rare disease
.

This is a hands-on role where you'll take ownership of clinical data management activities across Phase II-IV studies
, working closely with Clinical Operations, Biometrics, Data Science and Sponsor teams.

• Develop and maintain Data Management Plans (DMPs) and data validation specifications
• Support eCRF/EDC design and clinical database development
• Lead data review, cleaning, validation and site query management
• Manage clinical coding including MedDRA and WHO Drug
• Support adverse event/SAE reconciliation and safety data requirements
• Work with multiple data sources including eCOA/ePRO, laboratory, biomarker, EHR, omics and wearable data
• Coordinate data transfers and integrations
• Manage activities through to Database Lock
• Produce data management metrics and KPIs
• Work closely with internal teams and external Sponsors to ensure high-quality, compliant data delivery

You’ll have 5+ years' clinical data management experience
, ideally gained within pharma, biotech, CRO or a clinical research environment.

You’ll bring strong experience across:

• Phase II-IV clinical studies
• Clinical data review, cleaning and validation
• EDC/eCRF design and edit checks
• MedDRA and WHO Drug coding
• Safety data and SAE reconciliation
• Taking clinical databases through to database lock
• Working within ICH-GCP and relevant regulatory requirements

Experience with in oncology and/or rare disease would be particularly valuable.

We’re looking for someone who can work independently, take ownership of their studies and communicate confidently with both internal teams and Sponsor stakeholders.