| OBJECTIVES/PURPOSE (3-4 bullets) - Manage required business administration tasks and responsibilities in relation to Operational Data Systems
- Troubleshoot system issues; Work closely with business system lead to identify and track business needs and opportunities for future system upgrades
- Lead and manage user access request forms including verification of training and access approval for Operational Data Systems
- Manage and produce high quality end user central support model processes and materials, including but not limited to system procedures, guidances, tools, and forms
Technology & Data
- Troubleshoot system issues and help define enhancements; Work closely with business system lead/SME to identify and track business needs and opportunities for future system upgrades
- Responsible for fulfilling required business administration tasks and responsibilities in relation to Operational Data Systems including; centralized Inbox management, Global directory management, Study Creation, Loader sheet creation and support, and other data creation requests
- Responsible for managing user access request forms including verification of training and access approval for Operational Data Systems; Work with key stakeholders to coordinate auditor/inspector access (as needed)
- Lead and participate in the development and delivery of end-user training, access and central support model for GDO managed operational systems and/or inputs into R&D systems (e.g., Veeva Vault Clinical, CTMS, Trial Listings Solution, HCP Engagements etc.)
- In collaboration with key stakeholders, support data and documentation requests for audits, regulatory inspections and/or other internal purposes
- Liaise with IT Technology Leads and Business Stakeholders to resolve system issues and help define enhancements; Work closely business teams, identify and track business needs and opportunities for future system upgrades
- Manage framework for assessing tracking and managing end user compliance with operational system standards
Other
- May deliver educational training in relation to operational data systems
- May serve and/or support SMEs as a key point of contact for operational data systems including liaising with key stakeholders and impacted functional areas within R&D
- Seek opportunities to actively participate in process optimization initiatives; Provide input and identify opportunities to leverage operational data and/or technology to further optimize in support of an outsourced trial operating model including considerations for oversight requirements, predictable trial delivery and industry best practices
- Assist in data stewardship for GCO and I&D managed operational systems and/or inputs into R&D systems (e.g., Veeva Vault Clinical)
Other duties as assigned.
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EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
- Bachelor's degree preferred or commensurate with experience
- 3+ years experience in pharmaceutical, project administration and/or administrative role.
- Experience with clinical operations technologies desired (e.g. Veeva)
- Understanding of system development lifecycle requirements and US CFR/ICH GCP
- Knowledge of data stewardship principles and methodologies such as data quality, data governance and/or master data management
- Experience with Microsoft Office (Excel, Word, PowerPoint, Outlook, TEAMS)
- Strong written/verbal communication skills and project management skills
- Demonstrated ability to work well within a matrixed environment, and an ability to build solid relationships / make connections across the organization
- Ability to manage and provision large datasets with a high degree of performance and trust
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