Computer Systems Validation Specialist

Who We Are

Theradex Oncology is a full-service CRO, conducting early-phase oncology trials in the U.S., Europe and Asia. Theradex Oncology was founded in 1982. In the same year, we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our association with NCI has continued to be a strong basis for our operations. We are specialists. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and performed more than 250 early-phase oncology trials to date. Our mission is to secure that new opportunities in drug development have the very best chance to be of benefit to mankind with a vision to make cancer a liveable disease

What You'll Do

We are recruiting for a Computer Systems Validation Specialist for our US Headquarters. This is a remote/home-based position. 

The primary responsibilities of this position include, but are not limited to, the following:

• Perform risk analysis to determine validation deliverables needed for a project.
• Rely on extensive experience and judgment to plan and accomplish goals.
• Write Test Scripts and create Traceability Matrix and Test Reports.
• Execute Test Scripts, closely adhering to SOPs for test evidence and signoffs.
• Maintain SOPs for User Access, Change Control, System Validation, and study set-up. Write new SOPs as needed.
• Analyze data, prepare and review test results, and write validation reports.
• Mentor staff that assists in test execution and test documentation.
• Provide feedback on User Requirements Specifications and Functional Requirements Specifications.
• Create Validation Packages that includes all necessary components.
• Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations.
• Represent department in cross-functional teams and GXP-related problem resolution.
• Perform project management of validation projects.
• Provide leadership and guidance to ensure Theradex compliance with SOPs and GCP regulations.
• Manage time effectively. Accurately estimate effort for tasks and meet agreed-upon deadlines.
• Effectively juggle ad-hoc requests and longer-term projects.
• When roadblocks, defects, or scheduling challenges are encountered in testing, find solutions to enable successful and on-time completion of validation projects.
• Identify ways to streamline processes in validation, while not compromising adherence to SOPs and GCP regulations.
• Ensure the quality of all production releases of validated software.

What You Need

• Requires a bachelor’s degree
• 10+ years’ experience in computer systems validation, including significant experience working with minimal direction.

Skills and Competencies

• Detailed knowledge of computer system validation and all GCP (Good Clinical Practice) regulations.
• Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies.
• The employee must conduct their work activities in compliance with all relevant regulations, ICH, and CFR guidelines as well as all company policies, and procedures.
• Technical abilities and skills in understanding system logic, problem-solving, and trouble-shooting techniques.
• Strong written and verbal communication skills.
• Demonstrated ability to manage system projects.
• Strong time-management and organizational skills, with a record of being flexible, accurate, detail-oriented, reliable and self-motivated.
• Excellent negotiation skills and conflict management skills.
• Attention to detail with high quality outputs.
• Ability to work in a team environment, as well as independently.

Relocation assistance and company provided sponsorship is not available for this position.  

What We Offer

We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.   

Theradex is an Equal Opportunity Employer.