Senior Lead Clinical Data Manager

GE HealthCare

. Provide technical oversight for data management plans, validation specifications, CRF development, and other data management documents .

Posted 11/2/2026full-timeBuc • FranceSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Clinical Data Management, including oversight of EDC systems, data integrity, and regulatory compliance. Proficient in coordinating data management activities and ensuring quality standards are met across projects.

Highest-signal resume keywords

Clinical Data Management ExperienceElectronic Data Capture (EDC)CDISC SDTM KnowledgeUATs and Data CleaningOracle Clinical and Medidata Rave Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Data ManagementElectronic Data Capture (EDC)UATsData CleaningEdit-Check DefinitionData ReviewData TransfersReconciliationsECRF DesignSAS Programming

Soft Skills

Excellent Oral CommunicationExcellent Written CommunicationOrganizational SkillsAdaptabilitySelf-Motivation

Tools & Technologies

Oracle ClinicalMedidata RaveOracle InFormETMF

Industry Keywords

GCDMPICHQuality ComplianceData Management PlansValidation Specifications

Tech Stack

Tools & technologies

Oracle

About the role

Key responsibilities & impact

Provide technical oversight for data management plans, validation specifications, CRF development, and other data management documents
Coordinate data management activities between vendors and project teams
Review and approve EDC specifications and requirements documents, including performing and approving UATs
Review annotated CRFs, data-validation plans, data-transfer specifications, and reconciliation plans
Ensure activities leading to database lock are followed and documented, including SAE reconciliation and clinical coding review and approval
Facilitate resolution of technical data issues requiring clinical or regulatory input
Oversee EDC system design and development
Ensure the eTMF is maintained
Oversee project development and timelines
Ensure data management partners achieve KPIs across projects
Contribute to biometry process improvement
Comply with GE HealthCare quality policies, quality goals, laws, and regulations
Complete required Quality and Compliance training
Identify and report quality or compliance concerns and take corrective action
Ensure data integrity and regulatory and quality compliance of deliverables

Requirements

What you’ll need

At least 10 years of Clinical Data Management experience
Minimum 5 years of experience in EDC
Minimum Bachelor’s degree in Science or a related field
Experience with Oracle Clinical, Medidata Rave, Oracle InForm, or related clinical systems
Solid experience in UATs, data cleaning, edit-check definition, data review, data transfers, and reconciliations
Significant knowledge of CDISC SDTM
Working knowledge of good-practice regulatory guidance, including GCDMP and ICH
Working knowledge of English
Degree in computer science preferred
Experience in eCRF design and SAS programming is a plus
Excellent oral and written communication skills
Ability to organize and adapt
Self-motivated with a proven ability to work to deadlines

Benefits

Comp & perks

Total rewards, including salary and social benefits
Career development opportunities
Collaborative and supportive culture
Relocation assistance is not provided