Interacts with internal and external project team members (including external data source vendors) for multiple projects, as appropriate. Actively contributes to study team discussions, standing meeting agendas, meeting attendance and review and/or documentation of minutes.
Ability to facilitate clinical database development to properly execute collection, receipt, reporting, review and archiving of quality clinical trial data. Includes eCRF planning discussions, coordination of eCRF review, planning and identification of system and protocol specific edit checks, coordination and proper execution of User Acceptance Testing, and coordination, planning and development for external data sources as needed.
Participates in early study team planning of data risk assessment and continuous evaluation of risks throughout course of study. Ability to offer insight or mitigate risks of data loss.
Communicate with assigned data team members to ensure tasks are coordinated and executed as per study plans and timelines as appropriate. Ensure training of study specific protocol requirements as appropriate. Identify and communicate gaps in training and support training of data reviewers.
Ability to create, maintain, execute and properly store data related documentation as outlined in department operation procedures and as required by study
Responsible for functional area eTMF filing and quality control activities or equivalent as per study. Participation in internally and externally managed study audits as required.
Oversee study budget applicable to functional area. Identify and communicate potential out of scope activities to project team as appropriate. Work with study team to provide needed information for re-scoping when applicable.
Responsible for proper generation, review and reporting of study metrics and financials as needed
Execute all tasks as aligned with SOPs, department guidelines and data standards
2 weeks ago
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