Job Overview:
Minimum 23-year experience in a similar job in pharmaceutical companies international CRO or providers of clinical digital services
- Reports directly to the FSP Fortrea Line Manager.
- Receives projects-specific requests and strategic-operational guidance from the Head of Clinical Innovation Head of Clinical Feasibility Clinical Digital Health Lead.
Summary of Responsibilities:
- Contribute to GCD digitization by promoting innovative approaches and delivering training on new technologies.
- Develop and maintain the GCD website (Clinical Trial Website & Share Point management).
- Administer clients iMedidata Cloud and EDC system (Medidata RAVE).
- Provide technical support for configuration of clients EDC modules (e.g. Targeted Source Data Verification) at the study level.
- Integrate GCD electronic systems as applicable.
- Support the deployment and day-to-day management of digital health technologies (e.g. eCOA/ePRO wearables decentralized trial platforms) in clinical studies.
Digital Project Management:
- Planning
- Technical support
- Oversight of deliveries
- Documentation
- System validation
- Support GCD electronic system validation in collaboration with relevant R&D/GCD functions.
- Interact with company stakeholders (e.g. R&D QA R&D digital team GICT) on digital matters.
- Provide technical support and training to study teams and site staff on digital health platforms.
- Serve as a point of contact for troubleshooting and resolving operational issues related to digital tools.
- Gather user feedback and contribute to continuous improvement of digital health processes.
Compliance & Quality:
- Ensure digital health activities comply with GCP ICH GDPR HIPAA and internal quality standards.
- Support data security and patient privacy initiatives in collaboration with compliance and QA teams.
- Liaise with internal teams (clinical data management IT) and external partners (vendors CROs) to coordinate digital health activities.
- Participate in meetings and provide updates on digital health project status and operational challenges.
Learn more about our EEO & Accommodations request here.
Required Experience:
Manager
Job Overview:Minimum 23-year experience in a similar job in pharmaceutical companies international CRO or providers of clinical digital servicesReports directly to the FSP Fortrea Line Manager.Receives projects-specific requests and strategic-operational guidance from the Head of Clinical Innovation...
Job Overview:
Minimum 23-year experience in a similar job in pharmaceutical companies international CRO or providers of clinical digital services
- Reports directly to the FSP Fortrea Line Manager.
- Receives projects-specific requests and strategic-operational guidance from the Head of Clinical Innovation Head of Clinical Feasibility Clinical Digital Health Lead.
Summary of Responsibilities:
- Contribute to GCD digitization by promoting innovative approaches and delivering training on new technologies.
- Develop and maintain the GCD website (Clinical Trial Website & Share Point management).
- Administer clients iMedidata Cloud and EDC system (Medidata RAVE).
- Provide technical support for configuration of clients EDC modules (e.g. Targeted Source Data Verification) at the study level.
- Integrate GCD electronic systems as applicable.
- Support the deployment and day-to-day management of digital health technologies (e.g. eCOA/ePRO wearables decentralized trial platforms) in clinical studies.
Digital Project Management:
- Planning
- Technical support
- Oversight of deliveries
- Documentation
- System validation
- Support GCD electronic system validation in collaboration with relevant R&D/GCD functions.
- Interact with company stakeholders (e.g. R&D QA R&D digital team GICT) on digital matters.
- Provide technical support and training to study teams and site staff on digital health platforms.
- Serve as a point of contact for troubleshooting and resolving operational issues related to digital tools.
- Gather user feedback and contribute to continuous improvement of digital health processes.
Compliance & Quality:
- Ensure digital health activities comply with GCP ICH GDPR HIPAA and internal quality standards.
- Support data security and patient privacy initiatives in collaboration with compliance and QA teams.
- Liaise with internal teams (clinical data management IT) and external partners (vendors CROs) to coordinate digital health activities.
- Participate in meetings and provide updates on digital health project status and operational challenges.
Learn more about our EEO & Accommodations request here.
Required Experience:
Manager
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