Clinical Data Manager

We are looking for 3-5 individuals to start on a freelance basis within the next 2-4 weeks.

These are 1 year long contracts with the view to extend.

Position Summary

We are seeking an experienced and motivated Clinical Data Manager to join our growing Clinical Data Management team. This individual will be responsible for the end-to-end management of clinical trial data across Phase I-III studies, ensuring the delivery of high-quality, accurate, and regulatory-compliant datasets that support clinical development programs.

The successful candidate will possess strong experience in electronic data capture (EDC) systems, particularly Oracle RDC/Inform and Medidata Rave, and will work closely with Clinical Operations, Biostatistics, Medical Monitoring, Programming, Sponsors, and external vendors throughout the clinical trial lifecycle.

Key Responsibilities

• Lead clinical data management activities for Phase I-III clinical studies from study start-up through database lock.
• Develop and review Data Management Plans (DMPs), Data Validation Plans (DVPs), CRF completion guidelines, and other study-specific documentation.
• Design, review, and validate electronic Case Report Forms (eCRFs) within Oracle RDC/Inform and Medidata Rave.
• Coordinate database build specifications and user acceptance testing (UAT).
• Develop and manage edit check specifications to ensure data quality, consistency, and completeness.
• Review data listings and metrics to identify trends, discrepancies, and potential data issues.
• Generate, review, and resolve data queries with investigational sites and study teams.
• Oversee external data transfers from central laboratories, imaging vendors, ePRO/eCOA providers, biomarkers, and other third-party sources.
• Perform data reconciliation activities across multiple data sources.
• Ensure compliance with ICH-GCP, CDISC standards, sponsor requirements, and applicable regulatory guidelines.
• Support medical coding activities utilizing MedDRA and WHO Drug dictionaries.
• Participate in study team meetings and provide data management expertise throughout study conduct.
• Lead database lock activities and ensure timely delivery of clean datasets for statistical analysis.
• Support regulatory inspections, sponsor audits, and quality assurance reviews as required.
• Contribute to process improvement initiatives and development of departmental best practices.

Required Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Statistics, Computer Science, or related discipline.
• Minimum 3 years of Clinical Data Management experience within a CRO, pharmaceutical, or biotechnology environment.
• Demonstrated experience managing data for Phase I, II, and III clinical trials.
• Strong hands-on experience with:
• Oracle RDC / Oracle Inform
• Medidata Rave
• Experience designing and testing eCRFs and database specifications.
• Knowledge of ICH-GCP, FDA, EMA, and global data management regulations.
• Experience with data cleaning, discrepancy management, query resolution, and database lock processes.
• Familiarity with MedDRA and WHO Drug coding dictionaries.
• Strong understanding of CDISC standards including SDTM and controlled terminology.
• Excellent organizational skills with the ability to manage multiple projects simultaneously.
• Strong communication and stakeholder management skills.