Lead Validation Specialist

Theradex Oncology; Princeton (NJ); Remote; USD 125,000 - 150,000; Full time

Job summary

A leading clinical research organization is seeking an experienced Lead Validation Specialist. The role involves ensuring clinical systems are validated and compliant with GxP regulations. The ideal candidate has over 8 years of experience in validation and team leadership, strong skills in relational databases like Oracle and MS SQL, and a Bachelor's degree. This is a remote position with a salary range of $125,000-150,000.

Benefits

Medical, dental and vision coverage

Company matched 401(k)

Competitive tuition reimbursement

Flexible work schedules

Qualifications

• 8+ years prior experience in computer systems validation.
• 5+ years leading a validation team.
• Experience working with GxP regulations and 21 CFR Part 11.

Responsibilities

• Provide project leadership for the validation team.
• Ensure clinical systems are validated and maintained.
• Create, execute, and maintain validation strategies.

Skills

Computer Systems Validation

Analytical Skills

Communication Skills

Time Management

Education

Bachelor's degree

Tools

Oracle

MS SQL

Excel

Job description

Who We Are

Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

What You'll Do

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

Opportunity

Lead Validation Specialist

Location: Remote – Preference given to applicants residing in the East Coast.

We are seeking an experienced Lead Validation Specialist with experience in clinical systems to join our team. In this role, you will provide project leadership for the validation team and be responsible for ensuring that clinical systems are validated and maintained in compliance with GxP regulations and 21 CFR Part 11. You’ll work cross-functionally with validation, developers and SMEs to support rapid development timelines while upholding regulatory standards. You’ll be responsible for creating, executing, and maintaining validation strategies and documentation where scope and requirements can shift quickly.

This is an ideal opportunity for someone who thrives in fast-paced, dynamic environments where adaptability, critical thinking, and initiative are essential.

What You Need

• Bachelor’s degree
• 8+ years prior experience inclusive of computer systems validation
• 5+ Years relevant experience in Leading a Validation Team
• Strong experience working with relational databases (Oracle, MS SQL) to ensure data integrity in compliance with ALCOA+
• Experience working with GxP regulations and 21 CFR Part 11
• Experience mentoring and coaching teams
• Prior experience working in a Life Science regulated industry
• Prior project management experience, preferred

Skills and Competencies

• Computer Systems and Technology: Strong knowledge of computer systems validation (SDLC, Agile methodologies) web technology, and cloud-based systems and proficiency with Computer skills including advanced knowledge of excel (e.g. Microsoft Word, Excel spreadsheets, PowerPoint, SQL)
• Analytical and Problem-Solving Skills: Ability to research, analyze system requirements, develop alternatives, and implement solutions
• Communication and Interpersonal Skills: Strong verbal and written communication skills as well the ability to work both independently and with cross-functional teams
• Time Management Skills: Highly organized, result-oriented, and a self-starter comfortable working in fast-paced environment with evolving priorities

Additional Requirements

• Able to work effectively as an onsite or remote worker
• Must be highly fluent in English
• Willing to travel to meetings as needed. Advance notice will be provided

What We Offer

At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $125,000-150,000 with bonus potential. The actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role.

This position is not eligible for relocation or company provided sponsorship.

Theradex is an Equal Opportunity Employer.