- 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.
- Review EDC specifications from Lead Data Manager.
- Writes and assembles critical validation documentation packages including the Validation Plan, Testing Results, Traceability Matrix, and Validation Report.
- 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 System Development Life Cycle.
- Executes test cases against these requirements, enter errors in to error tracking logs and performs retests documenting resolutions, and maintain validation testing documentation and files.
- Demonstrate the ability to multi-task and manage validation activities for a project effectively.
- Plan and establish timelines to meet or exceed client expectations for validations.
- Review clinical project specification documentation to create appropriate testing methodologies.
- Write and review validation documentation to support projects.
- Work with other team members to create appropriate testing environments to support the testing methodologies.
- Utilize strong working knowledge of SOPs, validation standards, and work procedures to suggest potential improvements and to provide training and guidance to all clinical staff.
- Customer Facing
- 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.
- Staff and Financial Management
- Understand implications of activities to project budgets.
- Process Improvement
- Suggest process improvements where issues are seen.
- Support Six Sigma process improvement teams.
- Training / SOPs
- Reviews training materials for staff.
- Mentor and support other clinical employees in their understanding and adoption of validation concepts and responsibilities.
- Active member of SOP review teams as assigned.
- Lead or assist with special projects as designated.
Perform other duties as assigned by management
- BS/BA degree preferably in the sciences or related field, or two (5.5) years in a validation or regulatory position dealing with SOPS and computer systems requirement specification.
- Minimum 5.5 to 8 years of pharmaceutical or equivalent experience.
- Strong attention to detail.
- Strong analytical skills, preferably in a GCP environment.
- Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
- Problem Solving/Logic Skills.
- Strong communication and interpersonal skills.
- Strong MS/Office skills in particular with Excel and Word.
- Understanding of Electronic Data Capture (EDC) and the clinical trial process preferred.
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