About this role
Manage and coordinate core lab study data (including PSG, MWT, MSLT, PVT, EEG, ECG) for clinical studies and site certification. You will lead training, documentation, timelines, data QC, query resolution oversight, and regulatory binder preparation while ensuring compliance with Good Clinical Practices.
Key Responsibilities
- Serve as Corelab Project Manager on studies and/or site certification (device management, scoring reliability)
- Lead and guide Data Coordinators
- Manage project timelines, quality issues, and stakeholder communications
- Perform data entry and data QC; evaluate submitted data vs protocol criteria
- Generate and track queries and oversee query resolution while maintaining study databases and regulatory binders
Technical Overview
This is a clinical data management and project execution role focused on core lab operations. You will work with study databases, perform data entry and data QC, generate and track queries for resolution, and maintain electronic regulatory binders and documentation, using Microsoft Windows and Microsoft Office Applications plus Clinilabs collaboration.
Ideal Candidate
The ideal candidate is a mid-level Core Lab / Data Coordinator professional with 5+ years of experience supporting clinical studies and managing core lab data. They are strong in documentation, project timeline management, and data QC, with hands-on experience coordinating queries and maintaining study databases in compliance with Good Clinical Practices.
Must-Have Skills
5 years of experience in a Data Coordinator role and/or comparable rolesStrong computer (Microsoft Windows and Office Applications) and communication (oral and written) skillsMust have detailed documentation and project management skillsFollow and ensure compliance with current Good Clinical PracticesAdhere to corporate policies and procedures
Nice-to-Have Skills
Bachelor’s degree
Tools & Platforms
Microsoft WindowsMicrosoft Office ApplicationsClinilabs
Required Skills
Corelab Project ManagerData CoordinatorCore lab data managementPSGMWTMSLTPVTEEGECGdevice managementscoring reliabilitytraining and delegationproject timelinesquality issuestraining/reference materials and presentationsstudy-specific SOPselectronic regulatory binderscreening bindersGood Clinical Practicesdocumentation and project managementMicrosoft WindowsMicrosoft Office Applicationsbudget/finance trackerchange order managementdata QCquery generation and trackingquery resolutionstudy database managementClinilabs
Hard Skills
Core lab data managementPSGMWTMSLTPVTEEGECGdevice managementscoring reliabilitydata entrydata QCquery generationquery resolution trackingstudy database managementdata processing timelinesselectronic regulatory binderscreening bindersGood Clinical PracticesGood Clinical Practice compliancebudget/finance trackerchange order managementdata submission evaluationdata analysisSOP developmentstudy-specific SOPsdocumentation managementtraining materials developmentpresentation developmentMicrosoft WindowsMicrosoft Office Applicationsoral communicationwritten communicationdocument filing and storage
Soft Skills
leadership and guidancecommunication and working relationshipsproject managementdetailed documentationstakeholder managementcross-functional collaborationproblem resolution oversightflexible scheduleability to work outside normal business hourson-call rotation willingnesspoint-person collaborationtraining and delegation
Keywords for Your Resume
Corelab Project ManagerProject ManagerData CoordinatorData entrydata QCquery generationquery resolutionquery resolution trackingstudy databasedata managementGood Clinical PracticesGood Clinical PracticePSGMWTMSLTPVTEEGECGSOPstudy-specific SOPselectronic regulatory binderMicrosoft WindowsMicrosoft Office Applicationsbudgetchange order managementClinilabs
Deal Breakers
Must have at least 5 years of experience in a Data Coordinator role and/or comparable roles, Must demonstrate detailed documentation and project management skills, Must be able to follow and ensure compliance with current Good Clinical Practices, Must be available for flexible schedule and potential on-call rotations (outside normal business hours)
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