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Clinical Data Manager I

East Hanover, NJ, United StatesRemoteContract

AI Summary

Clinical Data Manager I reviews and manages clinical trial data, identifies and resolves data inconsistencies in CRFs, supports database cleaning and lock, and assists in protocol and validation document preparation.

About this role

Clinical Data Manager I

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Responsible for providing timely and prefessional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared clean and locked according to strict performance standards.

Review and contribute to the development of trial validation plan related documents and create/approve final CRF design, validation checks and reports necessary to assure high quality and consistent data. Review and contribute to the preperation of protocols, CRF's and prepare or review/contribute to operations manuals.

Organize / chair data management meetings. Support and assist clinical data managers, clinical data assistants for allocated trials. All other duties as assigned.

Support data management activities such as clinical data review, third party data reconciliation including ECGs, central lab, biomarker, IVRS, PK, SAE reconciliation and local lab data review


Skills:

1-3 years in clinical data management

pharma/CRO industry experience


Qualifications

BA/BS

Additional Information

For more information, Please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960


Skills

BiomarkerCentral LabClinical Data ManagementCRF DesignData ReconciliationData ValidationECGIVRSPKSAE Reconciliation

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