Position Details

Type Not Specified

Experience mid

Exp. Years 5 years

Education BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure

Category Data & Analytics

About this role

Homebased Clinical Data Manager (FSP) with emphasis on scientific (complex) data review in oncology, cardiovascular, and immunology, collaborating with SRP/SRS and the data management team to ensure compliant data capture and review.

Key Responsibilities

Lead scientific data review for multiple trials
Collaborate with SRP/SRS and DM teams
Review data flows and DMPs; ensure quality and regulatory compliance
Manage eCRF build and data reconciliation activities
Ensure inspection readiness and regulatory audits

Technical Overview

Extensive Rave/EDC experience; lead scientific data review activities; manage eCRF builds and DM deliverables; ensure regulatory compliance (ICH-GCP/SOPs).

Ideal Candidate

The ideal candidate is a homebased Clinical Data Manager with 5+ years in data management and strong Rave/EDC expertise, capable of performing complex scientific data reviews in oncology or cardiovascular/immunology trials.

Must-Have Skills

BS/BA degree or higher preferably in Health Sciencesor BS/BA degree or higher with professional clinical experience/exposure5 years Data Management experience performing scientific (complex) clinical data reviewRave knowledge and experience mandatoryExperience in supporting the eCRF build

Nice-to-Have Skills

Knowledge in medical terminology would be preferableExperience with data management tools beyond RaveExperience collaborating with SRP/SRS and data management teams

Tools & Platforms

Medidata RaveElectronic Data Capture (EDC) systemseCRF tools

Required Skills

RaveMedidata RaveeCRFeCRF builddata managementclinical data reviewICH-GCPSOPsregulatory guidelines

Hard Skills

RaveMedidata RaveeCRFelectronic Case Report FormCDMClinical Data ManagementSOPsICH-GCPICH GCPdata reviewRegulatory guidelines

Soft Skills

leadershipcollaborationcommunicationproblem solving

Industry & Role

Industry Healthcare & Medical

Job Function Provide scientific data review support for complex clinical trials within the data management function, ensuring alignment with SRP/SRS and DM teams.

Role Subtype Data Team Lead

Keywords for Your Resume

clinical data managerdata managementRaveMedidata RaveRave knowledgeeCRFeCRF buildICH-GCPSOPsdata reviewClinical Data ManagementCDDData Management Plansdata management documentstherapeutic area oncologyCardiovascularImmunologyclinical data managementEDC systems

Deal Breakers

No Rave/EDC experience, Lacking 5+ years of data management with scientific review

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Clinical Data Manager - homebased (FSP)

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