Job Description

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

• Demonstrate the ability to multi-task and manage validation activities for a project effectively.
• Create and Execute validation test scripts and document the test results.
• Plan and establish timelines to meet or exceed client expectation for validations. Review clinical project specification documentation to create appropriate testing methodologies.
• Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to Validation process.
• Write and review validation documentation to support projects.
• Work with other team members to create appropriate testing environments to support testing methodologies.
• 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.
• 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.
• Perform other duties as assigned by management.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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