Senior Data Management Lead - EDC & Trial Data Expert

GE HealthCare (United States); Folly Gate; On-site; GBP 60,000 - 90,000; Full time

Job summary

GE Healthcare is seeking a Clinical Data Manager to lead technical oversight in data management plans, EDC development, UATs, and data integrity across trials. The role requires extensive experience in EDC systems and regulatory compliance, with strong communication and organizational skills.

The candidate will coordinate with vendors and project teams, maintain the eTMF, and ensure timely delivery of DM deliverables while meeting quality standards and KPIs.

Qualifications

• At least 10 years of Clinical Data Management experience with a minimum of 5 years in EDC, preferably Medidata Rave, Ennov or Veeva Vault.
• Bachelor's Degree in Science or related field.
• Experience with Oracle Clinical, Medidata Rave, Oracle InForm or similar clinical systems.
• Significant knowledge of CDISC-SDTM.
• Experience in eCRF design and SAS programming is a plus.
• Knowledge of regulatory guidance (GCDMP, ICH) is preferred.

Responsibilities

• Provide technical oversight in developing data management plans, validation specifications, CRF development and other DM documents.
• Coordinate interactions between vendors and project teams related to DM activities and data transfer.
• Review and approve EDC specifications and related documents including UAT.
• Ensure database lock activities are followed and documented.
• Oversee design and development of the EDC system and maintain the eTMF.
• Monitor project timelines and ensure data management KPIs are met.
• Support regulatory compliance and quality requirements.

Skills

Communication skills

Organizational ability

Deadline orientation

Education

Bachelor's degree in science or related field

Tools

Medidata Rave

Ennov

Veeva Vault

Oracle InForm

Oracle Clinical

Job description

GE Healthcare is seeking a Clinical Data Manager to lead technical oversight in data management plans, EDC development, UATs, and data integrity across trials. The role requires extensive experience in EDC systems and regulatory compliance, with strong communication and organizational skills.

The candidate will coordinate with vendors and project teams, maintain the eTMF, and ensure timely delivery of DM deliverables while meeting quality standards and KPIs.