E-TMF Specialist - Parma

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

RESPONSIBILITIES:

• To adhere to eTMF SOP and other relevant TMF process supporting guidance, acting as eTMF Key-user for Clinical Trial Supply sections
• Central person to support processes, tools, and culture of the eTMF system for Clinical Trial Supply

EXECUTION AND COMPLIANCE

• Acquisition of documents in the eTMF and perform quality control (Investigational products and Clinical Trial Supply sections) using the company system
• Review eTMF Plan of clinical studies
• Monitoring of any anomalies and deviations of the eTMF system and involvement of the relevant functions (internal Company / CMO / CRO) until their resolution.
• Support to external users of the eTMF system (CMO) on the use of the same
• Support in the preparation of the study-specific RFP in relation to CTS eTMF services, if necessary.
• Archiving of documentation relating to CTS activities in the corporate CTS repository
• Operate according to cGMP, Company SOPs and Policies and Guidelines to accomplish daily tasks
• Support Quality Investigations for Deviations and Complaints
• Support Change Control Evaluation
• Collaborate to the identification of root cause analysis related to Department’s processes and tools
• Support GCD Clinical Operations during audits and/or regulatory Inspections in relation to TMF related matters
• Support for activities related to clinical trials CTS (packaging, labelling and distribution)

PROJECT GOVERNANCE

• Contribute to the definition of the Department strategy
• Collaborate with the CS Lead in the setup of CTS Documents Mapping for each Clinical Study
• The role is part of the eTMF Committee who governs standards and policies to maintain the TMF and ensure alignment with process and business requirements.

SOPS, GUIDELINES, WORKING INSTRUCTIONS AND TRAINING

• Authoring SOPs, Guidelines and Working Instructions
• Reviewing SOPs, Guidelines and Working Instructions
• Provide training on the job to Junior personnel and the CS Lead on specific topics related to eTMF system and documents management
• Support Department self-evaluation
• Support Competent Authorities (CAs) GMP and GCP inspections

INNOVATION AND TECHNOLOGY

• The role will help the Department improvement to develop and keep standards and policies to maintain the TMF and ensure alignment with CTS processes. The role contributes to the changes and updates to the eTMF system interacting with the eTMF vendor and necessary activities to keep the system in a validated state.
• The role helps to raise and maintain awareness across the organization of changes in the eTMF landscape, including both regulatory requirements and industry trends
• Propose sustainable and technological innovation related the eTMF documents management

REQUIREMENTS AND SKILLS:

• Scientific degree
• A significant experience in a similar job in the industry or CRO
• Demonstrated proficiency with TMF Management.
• Comprehensive practical knowledge of TMF processes, related standards and its quality control
• Working knowledge of clinical research documents
• Thorough understanding of ICH-GCP quality standards and other relevant regulations as applicable to management of clinical documentation
• Good knowledge of investigational medicinal products regulations and clinical operation processes
• Good knowledge of GMP
• Net-working and team working
• Action and results driven
• Orientation toward efficiency
• Orientation toward the clients
• Ability to manage stress
• Intuitive skills
• Capable of analysing, resuming and interpreting information
• Capable of planning and anticipating actions according to priorities and deadlines
• Capable of working efficiently with various teams
• Capable of creating and maintaining good relations
• Fluent English

TYPE OF CONTRACT:

Maternity replacement

Chemical 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.903/77).