Clinical Data Manager

Lead end-to-end clinical data management activities from study startup through database lock and archival.
Develop and review Data Management Plans (DMPs), Data Validation Plans (DVPs), Data Transfer Agreements (DTAs), and database specifications.
Oversee clinical database design, Electronic Case Report Form (eCRF) development, edit checks, and User Acceptance Testing (UAT).
Manage clinical trial data within Medidata Rave, Oracle Clinical, Oracle InForm, or Veeva Vault CDMS.
Perform data review, discrepancy management, query resolution, and reconciliation to maintain clinical data quality.
Coordinate external data transfers and reconciliation activities involving central laboratories, ECG, imaging, pharmacokinetics, and other third-party vendors.
Lead SAE reconciliation with pharmacovigilance and safety teams.
Oversee medical coding activities using MedDRA and WHO Drug dictionaries.
Review data listings, validation reports, and operational metrics to identify inconsistencies and outstanding issues.
Coordinate interim data cuts, database freezes, and final database locks.
Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, and Regulatory Affairs.
Provide technical oversight of CROs and external data management vendors, including deliverable reviews, timelines, and quality metrics.
Ensure compliance with ICH-GCP, applicable FDA regulations, 21 CFR Part 11, and organizational SOPs.
Support inspection readiness, audit responses, CAPA activities, and continuous process improvements.
Mentor junior clinical data management professionals and provide technical guidance on complex data issues

Work arrangement
Yes