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 strong 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 environments to support testing methodologies.
- Exhibit good imparting, analytical skills along with testing, troubleshooting, error fixing, and documentation skills.
- Conduct Peer Review/Quality control of study design for assigned projects.
- Utilize strong working knowledge of SOPs, validation standards, and work procedures to suggest potential improvements and to provide training and guidance to all critical staff.
- Assist in the support of regulatory and client audits of validation activities and documents.
- Support management of metrics.
- Assist with investigating or resolving issues of patient safety or quality as directed.
- Proactively identify trends, generate reports/metrics, or demonstrate Validation process to sponsors/auditors (if required), assist with the validation and other study documents.
- Understand implications of activities on project budgets.
- Suggest process improvements at various levels of validation process.
- Assist in developing key metrics for process improvement.
- Train, Mentor and support the team in their understanding and adoption of validation concepts and responsibilities.
- Active member of SOP review team as assigned.
- Lead or assist with special projects as designated.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- University / college degree (life sciences, health sciences, information technology or related subjects preferred).
- Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Fluent in English, both written and verbal.
Experience (Minimum Required):
- 4 - 6 years of relevant work experience to include Validation support and execution.
- Good problem-solving skills and a proactive approach.
- Strong communication and interpersonal skills.
- Strong attention to detail.
- Problem solving/logic skills.
- Good time management skills and maintain the highest standards of quality work.
- A neat, methodical, and thorough approach to the work with an emphasis on attention to detail.
- Good concentration skills are required to meet the consistently high standards expected.
- Self-motivation with the ability to work under pressure to meet demanding deadlines.
- Strong analytical skills and attention to detail, preferably in a GCP environment.
- Ability to prioritize work.
- Effective communication skills and the ability to work as part of a team.
- Flexibility - being able to move from one computer system to another with ease and adapt to new technology and a constantly changing work environment.
Preferred Qualifications Include:
- University / college degree (life sciences, health sciences, information technology or related subjects preferred).
Physical Demands/Work Environment:
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