Clinical Data Manager I

Perspectum Diagnostics Ltd.; Oxford; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

Perspectum Diagnostics Ltd. is seeking a Clinical Data Manager I to ensure clinical trial data is accurate, complete and compliant with study protocols and regulatory requirements.

You will collaborate with clinical operations, biostatistics and medical writing to support data collection, management and analysis, bringing a detail-oriented approach and passion for clinical research. The role involves managing EDC data entry and review, generating data queries, supporting database lock requests

Qualifications

• Bachelor’s degree in life sciences, engineering, or a related discipline.
• Strong organisational and prioritisation skills with ability to meet multiple deadlines.
• Excellent attention to detail and accuracy in data handling.
• Excellent communication and collaboration skills within cross-functional teams.

Responsibilities

• EDC data entry and review.
• Generate data queries and perform data validation on reconciliation.
• Assist with database lock requests.
• Monitor progress of data cleaning activities and data quality.
• Assist in database design, setup, testing and maintenance.

Skills

Organisation

Attention to detail

Communication & collaboration

Data & clinical trials passion

Education

Bachelor’s degree in Life Sciences / Engineering

Tools

EDC systems

CDM best practices

SDTM/CDISC standards

Job description

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.