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.
