Study Documentation Specialist at Kavaliro Wilmington, DE 19850
Study Documentation Specialist This opportunity will allow you to join one of the largest pharmaceutical companies in supporting the development of innovative medicines and devices worldwide.
As a Study Documentation Specialist responsibilities will include:
Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents.
Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.
Support the CRA in the maintenance and close out activities for the ISF.
Contribute to the production and maintenance of study documents, ensuring template and version compliance.
Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GELContribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.
e.
Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).
Set-up, populate and accurately maintain information in tracking and communication tools (e.
g.
IMPACT, SharePoint etc) and support others in the usage of these system QualificationsBachelor's degree is preferredExperience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documentsWorking knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines Working knowledge of clinical study documents3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents is requiredVeeva experience a plusAccountable and inquisitive; thinks outside the boxMust be methodical, compliant to processes yet flexible when neededApplicants must be currently authorized to work in the United States on a full-time basis.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
As a Study Documentation Specialist responsibilities will include:
Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents.
Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.
Support the CRA in the maintenance and close out activities for the ISF.
Contribute to the production and maintenance of study documents, ensuring template and version compliance.
Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GELContribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.
e.
Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).
Set-up, populate and accurately maintain information in tracking and communication tools (e.
g.
IMPACT, SharePoint etc) and support others in the usage of these system QualificationsBachelor's degree is preferredExperience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documentsWorking knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines Working knowledge of clinical study documents3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents is requiredVeeva experience a plusAccountable and inquisitive; thinks outside the boxMust be methodical, compliant to processes yet flexible when neededApplicants must be currently authorized to work in the United States on a full-time basis.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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