Etmf Specialist

On behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry a global pharmaceutical company - IQVIA is looking for a e TMF Specialist who can join an exciting working environment in a dynamic atmosphere.This position will oversee the global e TMF (electronic Trial Master File) operations for GRD R&D including providing support to all study teams members involved in e TMF management.Responsible for creation and revision of all e TMF associated procedures, ensuring they are up to date and compliant with the applicable regulations.This position will assume the leadership role for global e TMF operation to ensure the quality KPIs are met and e TMFs are inspection ready at all times.Role: Global oversight of the e TMFs, ensuring that the study teams are maintaining inspection ready files across all programs.Establish KPIs and metrics for documents filed in the e TMF to improve performance, quality, risk mitigation and contingency planning.Develop and embed process excellence and consistency across e TMFs management.Establish industry standard processes for e TMF by incorporating the applicable changes to the TMF reference model.Accountable to ensure consistency in e TMF management at all stages (e TMF set-up, maintenance, QC/ QR and query management, final reconciliation, closure, migration and archiving).Provide TMF support for both inspection and audit activities for internal and external hosted audits.This includes working directly with Agency Inspectors (FDA, EMA, PMDA, MHRA, etc) or auditors;assist with retrieving documents, speaking to the TMF process and assisting with resolving potential issues identified.Responsibilities:70% - TMF Management and Reporting: Handles and maintains electronic TMF and electronic internal repository according to ICH/GCP guidelines and applicable regulations/ standards.Responsible for preparing the periodic internal reports on e TMF healthiness and serves as an escalation point for the study team members involved in e TMF management.Liaise with the TMF vendor as required.Supports the study teams on e TMF audit and inspection readiness activities.20% - Due Diligence: Participates in Due Diligence activities related to TMF.Supports the team on gap analysis/ verification activities on TMFs acquired through acquisition.10% - Meetings: Organizes the periodic TMF Oversight meeting with the applicable parties.Ensure the required action items are distributed to the study teams and escalated as required.Required Skills: BS/BA in Life Sciences or similar discipline Minimum 5 years of experience in similar position in Pharmaceutical or CRO industry and in R&D environment Demonstrated individual and team leadership skills Extensive experience managing e TMF including set-up, maintenance, QC/QR and query management, final reconciliation, migration and archiving Experience with various e TMF systems;experience with Veeva Vault e TMF is preferred Strong knowledge of the TMF reference model Experience managing paper TMF is preferred Previous experience with internal/ external audits and inspection is an asset Knowledge of ICH GCP and applicable regulations Strong knowledge of Good Document Practice requirements & ALCOA++ principle Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global), and government agencies Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities and aggressive deadlines Proficient in MS Office (Word, Excel, Outlook, Project and Power Point) and Adobe;