IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Ensure efficient and appropriate management of the Clinical Document Processing activities and processes, as well as the Processing team. Coordinate the In-Licensing / Out-Licensing / Divestment Projects and ensure successful transition of TMF doc-umentation within/outside of Novartis.
Ensure high quality and efficiency of Clinical Document Processing standards in accordance with HA Guidelines, Good Clinical Practices, Novartis SOP's:
Support the Clinical Document Processing & Archiving Lead to define the strategy for the Processing activities Manage and coordinate the Processing services/activities and team (provided by external partner), including prioritization of projects, team assignments,
- Manage and globally coordinate the creation and/or update of applicable processes, Guidance documents, templates, etc... as applicable
Support with the budget planning/ forecast to ensure adequate delivery of processing services by the dedicated ESP Ensure business support for high quality, timely and efficient processing of paper and electronic documents.
- Keep oversight over processes and infrastructure for filing, indexing, archiving and retrieving of study documentation and ensure their compliance.
- Act as an SME for the document processing in the electronic Document Management Systems (CREDI/SubWay), i.e. Artifact / Doctypes, Naming Conventions, Attributes, Properties, etc
- Ensure quality, inspection-readiness, timeliness and efficiency of facility management and Clinical Documentation handling such as scanning, QC, technical fixes as well as management of exceptional (legacy documents, in-licensing/out-licensing documents) and time-critical documents.
- Ensure support in the preparation and during audits and inspections.
Coordinate and act as primary point of contact for the In-Licensing / Out-Licensing / Acquisition / Divestment Projects
- Coordinate the Clinical Documents Governance and Management activities (paper and electronic),
- Proactively and successfully, collaborate with key stakeholders including the Archiving team, other groups from Clinical Document Governance and Management, Development Informatics, Legal, Development Quality Assurance and Global Project Teams...
- Lead and/or Contribute to the development of the TMF Transition Plans
- Ensure successful transitions of TMF (paper and electronic)
Support the TMF Manager Outsourced Studies in the different Outsourcing strategies (e.g. direct import by ESP), Outsourcing processes, etc... Develop and maintain paper and electronic document processes & standards in compliance with internal and external requirements & regulations; own related SOPs or delegate ownership; support and/or drive improvements and innovation on business and technical aspects of TMF processing, including implementation of innovative methods. Promote best documentation practices to line functions to ensure that documents created/generated in the course of clinical research are managed and archived in accordance with GCP guidelines and Novartis SOPs
Key Performance Indicators (Indicate how performance for this role will be measured)
- Inspection-readiness of TMF Documentation and processes - no critical audit or inspection findings
- Timely and high-quality importing and filing of TMF documents (paper and electronic)
- Consistent and efficient use of Processing / Outsourcing Processes in Line Organizations
- Definition of quality standards for documents and document processing
- Life science university degree / Bachelor's degree in life science/healthcare is required with minimum 5 years' experience in clinical operations and / or clinical systems management
- Associate degree required with minimum 8 years' experience in clinical operations and / or clinical systems management
- Fluent English (oral and written)
- Experience in monitoring and quality control of deliverables provided by external vendors
- Knowledge of the technical requirements by FDA/EMA for submission documents
- Advanced ability to work both independently and in a global cross-functional multicultural and international team.
- Ability to lead globally distributed matrixed teams. Demonstrated ability to influence without authority.
- Demonstrated experience managing delivery from vendors
- Knowledge of clinical development process and/or document management (paper and/or electronic), regulatory requirements and Good Clinical Practice. Ability to translate trial information, processes and regulations into TMF documentation.
- Excellent attention to accuracy and details, organization and tracking skills.
- Good interpersonal, problem-solving, negotiation and conflict resolution skills.
- Good communication skills Ability to work under pressure
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and
Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.
Job ID: R1123463