Clinical Data Manager I: EDC & Data Quality Champion

Perspectum Ltd; Oxford; On-site; GBP 42,000 - 60,000; Full time

Job summary

Perspectum Ltd is seeking a Clinical Data Manager I responsible for ensuring trial data is accurate, complete, and aligns with study protocols and SOPs. You will collaborate with clinical operations, biostatistics and medical writing to support collection, management and analysis of data.

You are detail-oriented with a passion for clinical research and data management. The role involves EDC data entry, data queries, database design and participation in quality audits in line with ICH GCP.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• Experience with clinical data management and CDM processes.
• Familiarity with EDC and data capture systems.
• Knowledge of ICH GCP guidelines.
• Attention to detail and strong organizational skills.

Responsibilities

• EDC data entry and review.
• Generate data queries and perform data validation on reconciliation.
• Assist with database lock requests.
• Monitor the progress of data cleaning activities and the quality of the data.
• Assist in database design, set up, testing and maintenance.
• Assist with Data Transfer Agreements and Data Management Plan drafting.
• Manage EDC access.
• Ensure CDM activities conform to ICH GCP guidance.
• Lead and/or participate in audits of clinical data management processes.

Skills

EDC data entry

Data validation

Database lock

Data cleaning monitoring

Database design

Data management

Audits

Communication

Team collaboration

Education

Bachelor’s degree

Advanced degree

Tools

EDC systems

Job description

Perspectum Ltd is seeking a Clinical Data Manager I responsible for ensuring trial data is accurate, complete, and aligns with study protocols and SOPs. You will collaborate with clinical operations, biostatistics and medical writing to support collection, management and analysis of data.

You are detail-oriented with a passion for clinical research and data management. The role involves EDC data entry, data queries, database design and participation in quality audits in line with ICH GCP.