Job Overview:
Leads validation projects as assigned and serve as a validation team member on multiple assignments as designated by the management with support from other team members as needed. Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks to include creating, reviewing, and executing of validation documentation. Review Scope of work for the assigned project. Manage validation documentation packages including the Validation Plan, Testing Results, Traceability Matrix, and Validation Report. Assist project teams with validation tasks as requested, i.e., with the creation, production, printing and tracking of study documentation and controlled documents. Provide coordination of virtual global validation teams as needed to complete validation projects. Maintains and utilizes a solid knowledge of SOPS and validation work procedures/standards in relation to the Validation tasks.
Summary of Responsibilities:
- Demonstrate the ability to multi-task and manage validation activities for a project effectively.
- Lead the development and implementation of solutions to global technical services issues and concerns regarding Validation activities.
- Plan and establish timelines to meet or exceed client expectations for validations.
- Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to Validation process.
- Review clinical project specification documentation to create appropriate testing methodologies.
- Create and Execute validation test scripts as requested and document the test results.
- Write and review validation documentation to support projects.
- Able to work independently and take initiative to accept new challenges in the validation tasks and new or updates to software.
- Resource forecasting and allocate activities to the team members on the project.
- Work with other team members to create appropriate testing environmen