Job Overview

The Clinical Data Manager I is responsible for ensuring that clinical trial data is accurate, complete, and consistent with study protocol, standard operating procedures (SOPs), and regulatory requirements. They work closely with cross-functional teams, including clinical operations, biostatistics, and medical writing, to support the collection, management, and analysis of clinical trial data. They are a detail-oriented individual with a passion for clinical research and data management.

Duties and Responsibilities

Essential

• EDC data entry and review.
• Generating data queries and performing 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.

Desirable

• Assist with Data Transfer Agreements and Data Management Plan drafting.
• Manage EDC access.
• Database design, set up, testing and maintenance.
• Oversee/execute database lock requests.
• Ensure CDM activities conform to ICH GCP guidance.
• Lead and/or participate in internal and external audits of clinical data management processes.

Person Specification

Essential

• Bachelor’s degree in a relevant field (i.e., Life Sciences, Engineering, etc).
• Strong organisation and prioritising skills with ability to meet multiple deadlines.
• Excellent attention to detail and accuracy.
• Excellent communication and collaboration skills.
• Passion for working with data / clinical research / clinical trials

Desirable

• Advanced degree in a relevant field (i.e. Life Sciences, Engineering, etc).
• Certificate in Good Clinical Practise (GCP).
• Experience in CDM and knowledge of effective clinical data management practices.
• Knowledge of effective clinical data management practices.
• Experience working with Clinical Data Management and Electronic Data Capture (EDC) systems.
• Knowledge of Good Clinical Data Management Practices (GCDMP) and CDISC Study Data Tabulation
• Model (SDTM) standards.
• Experience within Medical Devices/Pharma/Clinical industry.
• Strong project and resource management skills with ability to manage multiple projects.
• Experience working with Quality Framework (ISO) standards (e.g.ISO27001, ISO13485) and ICH GCP,
• and understanding of 21 CFR Part 11 regulation.
• Proactive, analytical, and problemsolving skills with commitment for continuous improvement.