Clinical Data Manager I

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

Job Overview

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

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.

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.

Essential

Duties and Responsibilities

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

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.