28 days old


Kelly Services
Lawrence, NJ 08648
**BH: 3403801**

***** MUST BE ABLE TO WORK ON A W/2 HOURLY BASIS** **_(without Sponsorship)_** ******* **_NO C2C_** ***** 100% REMOTE ! *****

**Our Client is expanding and currently seeks a**


**_For a 12+ month assignment with possible extensions!!_**

**LOCATIONS:** Lawrenceville, New Jersey ( **Position is 100% remote!! )**

Summit, New Jersey

Tampa, Florida


**Leverage your UAT and VALIDATION skills**

**to help take your career with our Client to**

**the "Next Level" for 2021 and beyond!**

Our Client is seeking a Quality Assurance Tester / Computer Validation Compliance Specialist to become part their Computer Validation department.

A key focus of this role will be to provide quality/compliance oversight to all computer system validation related activities across the enterprise.

This position is responsible for the development and implementation of the Quality Assurance (QA) and User Acceptance program for IRT systems in support of clinical trials. The incumbent will have final responsibility for all QA and Test activities for assigned projects. This will require managing validation across multiple concurrent projects.


Advanced understanding of drug development process and regulatory requirements to execute global clinical trials.

Moderate/strong understanding of drug development process and regulatory requirements for clinical trials.

Strong Project Management skills with the ability to manage multiple projects simultaneously.

Strong understanding of industry technologies.

Advanced communication and negotiation skills.

Strong understanding of System Development Life Cycle (SDLC).

Strong vendor management skills.

Ability to drive multiple projects to deliver a quality system on time.

Strong analytical skills / influencing skills.

Strong knowledge of randomization and study drug management processes.

Strong understanding of legislative and regulatory requirements with respect to investigational drugs and supporting computerized systems.

Ability to evaluate the quality of complex studies such as; dynamic rand, complex titration and adaptive study design and validation.

Strong knowledge of clinical protocol analysis and its application including clinical study processes.

Ability to interpret and identify potential data unblinding scenarios.

Moderate understanding of relationship database practices.

Team and individual leadership.

Demonstrated broad computer program literacy including Visio, and Microsoft PowerPoint, Word, Excel.

Strong problem-solving skills.

Creative thinking.

Strong collaboration skills.

Maintains optimism and composure in times of change, uncertainty, or stress.

Encourages open exchange of information.

Maintains high quality while meeting deadlines and commitments.

Meets commitments to customers/clients; continually searches for ways to improve customer/client service; impresses customers with exceptional service or work; seeks feedback from customers.


Develops Quality Management Plan and Test Strategies for all projects assigned.

Manages the development of User Acceptance Test (UAT) approaches and documentation.

Responsible for determining acceptance criteria of systems.

Defines the UAT structure for developing, organizing and maintaining test cases.

Maintains all executed Test Assets generated by a project.

Assist the IVRS Central Management Team in developing and coordinating the UAT plan for each system.

Reviews and approves all project Test Deliverables and design specifications.

Collects, analyzes and reports on quality metrics for all projects and vendors.

Establishes and maintains a quality monitoring plan for live systems.

Participates as needed on the IVRS Central Management Team to ensure that members understand the quality management plan, test strategy, and quality processes.

Provides training on UAT processes and associated tools when necessary.

Gains stakeholder buy-in for quality initiatives such as promoting ongoing training and implementing best practices throughout the project.

Ensures sufficient infrastructure to support quality initiatives.

May assist with the development of processes and standards.

Collaborates and assists in management of vendor activities.

Independently makes decisions to ensure the effective resolution of issues as they develop.

Extensive travel may be required.

Performs other tasks as assigned.


4 year degree mandatory.

**Important information:**

+ **There is no per diem with this position**

+ **There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.**

+ **MUST be able to work without sponsorship or VISA transfer for this position.**


**Why Kelly** **** **?**

By partnering with Kelly IT, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2021-03-17 Expires: 2021-04-17

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Kelly Services
Lawrence, NJ 08648

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