Consultant – Early-Phase Data Manager

Ividata Life Sciences

. Serve as the data management subject-matter expert for complex clinical studies, particularly Early Phase, First-in-Human, and bioequivalence studies .

Posted 10/26/2026full-timeParis • FranceMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical data management, particularly in Early Phase and bioequivalence studies, with proficiency in EDC/eCRF tools and adherence to CDISC standards. Ensures regulatory compliance and effective collaboration with cross-functional teams in the pharmaceutical and biotechnology sectors.

Highest-signal resume keywords

Clinical Data ManagementEDC/eCRF Tools ProficiencyCDISC Standards KnowledgeSAS ProficiencyGood Clinical Data Management Practices (GCDMP)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data ManagementData CleaningDatabase LockUser Acceptance Testing (UAT)Medical CodingData Flow DefinitionData Review PlansValidation PlansReconciliation PlansInterim Data Reviews

Soft Skills

Attention to DetailOrganizational SkillsAnalytical MindsetExcellent Communication SkillsInterpersonal Skills

Certifications & Qualifications

Advanced Scientific Degree

Industry Keywords

Pharmaceutical IndustryBiotechnology SectorCRO IndustryEarly Phase StudiesFirst-in-Human StudiesBioequivalence StudiesEMA/FDA Regulatory FrameworksTrial Master File (TMF)SDTM SpecificationsVendor Management

Tech Stack

Tools & technologies

FluxTypeScript

About the role

Key responsibilities & impact

Serve as the data management subject-matter expert for complex clinical studies, particularly Early Phase, First-in-Human, and bioequivalence studies
Contribute to study design and setup, from drafting the data management sections of the protocol to developing eCRF specifications and defining data flows
Lead outsourced data management activities, participate in CRO selection, and monitor their performance, costs, timelines, and quality
Review and approve documentation deliverables, including the Data Management Plan, data entry guidelines, data review plans, validation plans, and reconciliation plans
Coordinate and execute eCRF User Acceptance Testing (UAT) before go-live and following protocol amendments
Oversee data quality and operational data management activities, including ongoing data cleaning, medical coding, external data transfers, and reconciliation of SAEs and laboratory/PK data
Prepare and document critical database freeze steps, interim data reviews, data cuts, and final database locks
Ensure regulatory and documentation compliance, including review of SDTM specifications and datasets and maintenance of the Trial Master File (TMF)
Collaborate with cross-functional teams and clients in the pharmaceutical and biotechnology sectors

Requirements

What you’ll need

Advanced scientific degree (Master’s degree in clinical data management, biostatistics, public health, or equivalent)
At least 5 years of clinical data management experience in the pharmaceutical, biotechnology, or CRO industry
Proficiency with EDC/eCRF tools and end-to-end data management processes, including UAT, edit checks, data cleaning, and database lock
In-depth knowledge of CDISC standards, particularly SDTM
Proficiency in SAS
Demonstrated experience managing and overseeing vendors/CROs
Knowledge of Good Clinical Data Management Practices (GCDMP) and EMA/FDA regulatory frameworks
Experience in early-phase studies (Phase I, FIH), healthy volunteer studies, or bioequivalence studies is a plus
Strong attention to detail, organizational skills, analytical mindset, excellent communication skills, and interpersonal skills for effective cross-functional teamwork
Fluency in English, both written and spoken, is essential

Benefits

Comp & perks

Remote work opportunities
A stimulating, collaborative, and constantly evolving environment
High-impact assignments
Work alongside passionate experts
The opportunity to make a real impact through your ideas and expertise