Clinical Data Manager

ABOUT THIS ROLE

We are an AI company building tools for clinical trial data management in the pharmaceutical industry. Our AI processes electronic data capture (EDC) exports, codes adverse events to MedDRA, flags data discrepancies, and raises queries — the same work clinical data teams do across hundreds of trials. We need clinical data managers and coders who can review our outputs and tell us, from real trial experience, whether what the AI is doing is right.

WORKFLOWS COVERED

• Clinical trial data review — edit checks, discrepancy management, and query resolution in EDC systems
• Medical coding of adverse events and medical history using MedDRA and WHO Drug Dictionary
• ALCOA-C data integrity checks across clinical datasets
• Data cleaning, database lock preparation, and transfer to biostatistics

WHAT YOU WILL DO

• Share how clinical data management and medical coding work in practice across the full trial lifecycle — from EDC setup and data review through to database lock
• Review coding outputs, data review processes, or quality check designs and tell us where they would fail real clinical data standards
• Help us understand the practical challenges of MedDRA and WHO Drug coding — the ambiguous cases, the version updates, the sponsor-specific conventions that vary across CROs
• Advise on what good clinical data quality looks like and flag where process descriptions or outputs diverge from real trial operations

YOU ARE THE RIGHT FIT IF

• Minimum 3 years in clinical data management or medical coding in the pharma or CRO industry — not hospital or insurance coding
• Have personally reviewed clinical datasets, coded adverse events, or run edit checks in EDC — not just project management
• Know the tools — Medidata Rave, Oracle Inform, Veeva Vault CDMS — from using them across actual trials (exposure to safety systems such as Argus Safety is a plus)
• Worked at organisations such as IQVIA, Parexel, Syneos Health, Covance, Pfizer, Novartis, AstraZeneca, or a similar pharma company or CRO

NICE TO HAVE

• CCDM certification (Society for Clinical Data Management)
• CDISC CDASH or SDTM experience — building or reviewing datasets
• Crossover into pharmacovigilance — experience with safety data and ICSR processing