Clinical Trial Administrator - ETMF Specialist 2

On behalf of our Client a global pharmaceutical company, IQVIA is looking for Document Management and Data Archiving Specialist who can join an exciting working environment in a dynamic atmosphere.

The profile will manage all Trial Master File (TMF) activities related to Data Management and Statistics, to guide and oversee DM/STAT providers, to ensure quality and TMF audit/inspection readiness.

RESPONSIBILITIES:

• Trial Master File

• To plan TMF activities for the assigned studies and to write / review the Trial Master File Plan
• To train, support and oversee DM/STAT CRO for TMF related activity, monitoring activities progress by using TMF metrics and ensuring activities are carried out with the expected quality and according to agreed timelines To upload documents in the electronic TMF for documents created internally
• To perform quality review of documents filed in TMF
• To participate / support audit and inspection to TMF
• To contribute to eTMF process improvement and internal system development

• Document Approval Coordinator

• To manage and coordinate the flow of the Case Report Form (CRF) approval in the internal electronic Documentation System
• To manage and coordinate the flow of the Statistical Analysis Plan (SAP) approval in the internal electronic Documentation System

• Electronic Data Archiving

• To create the study directories in the Biomed Archiving Folder and in the SAS Storage Area and controls the archiving directories to ensure compliance with the established rules
• To support data managers and statisticians in archiving electronic study documentation To perform quality controls of the study directories and their contents in order to ensure completeness and adherence with internal procedures
• To store the final data and metadata in the SAS Storage Area protected “ARCHIVE” folder according

REQUIREMENTS AND SKILLS:

• High School and/or College Degree
• A significant experience in a similar job in the industry or CRO
• Knowledge of drug development process English knowledge
• Solid knowledge of clinical data management and
• Good knowledge of SAS System
• Knowledge of international data standards (CDISC) and regulatory requirements for data submission
• Problem solving
• English Proficient

TYPE OF CONTRACT:

Permanent contract

IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com