Clinical Quality Assurance Specialist

Job Title: Clinical Systems II Contractor

Job Description

We are seeking a talented Clinical Systems II Contractor to join our team. This role involves coordinating and executing system plans, establishing objectives, and leading mid to large projects through implementation phases. The ideal candidate will have strong collaboration skills to work effectively with IT teams, internal and external partners, and external entities.

• THIS IS NOT A PROGRAMING ROLE!!!!*

MUST HAVE

• 5+ years of experience in CLINCAL RESEARCH OPERATIONS or CLINICAL QUALITY
• SOP Revision and Harmonization
• GCP, ICH and clinical quality systems
• US and EUMDR, Health Canada, ICH, ISO and CFR proficient
• Clinical Data Management
• Medical Device and EU MDR Experience!!!!
• Experience in editing PROCEDURES AND SOP's!!!
• Experience in virtualization and storage systems
• A minimum of a bachelor's degree in computer science, technical and/or scientific discipline.
• Industry experience in medical technology or pharma is preferred.
• Proficient in operating computer systems, with knowledge in CTMS, eTMF, DICOM/image management.
• Experienced in validating, qualifying, and auditing vendors, systems, and software.

Responsibilities

• Coordinate the development of systems plans, establish objectives, priorities, time allocations, and deadlines.
• Execute on plans and provide regular status reports to keep management informed of progress and project issues.
• Coordinate and collaborate with IT teams/management along with internal and external operational partners, business and clinical, as well as external entities as necessary to lead mid to large projects through the appropriate phases of implementation.
• Direct staff in providing first-line systems software support, troubleshooting and problem resolution services, liaising with corporate IT and software vendors as appropriate.
• Prepare validation documentation for all major products under the responsibility of the Clinical Systems team, following relevant regulatory guidelines and maintaining close collaboration with corporate IT teams.
• Ensure compliance with processes (SOPs) and subsequent documentation of clinical systems, including support documentation.
• Creation of repositories, development/maintenance processes, guidelines, and standards.
• Validation and maintenance of clinical databases.
• Consult with study managers and data managers during the Clinical Database Start-Up Process on design/specification questions.
• Independently lead and manage the User Acceptance Testing (UAT) process with stakeholders by gathering UAT results, then making any necessary database modifications until all problems are fixed.
• Create standard and ad hoc reports.

Work Environment

The position operates in a collaborative environment where teamwork with IT teams and external partners is crucial. The role may involve working with various computer systems, including CTMS, eTMF, and DICOM/image management technologies. The work environment encourages adherence to guidelines and standards, fostering a culture of compliance and continuous improvement. THIS IS A CONTRACT ROLE

Pay and Benefits

The pay range for this position is $60.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job

classification and length of employment. Benefits are subject to change and may be

subject to specific elections, plan, or program terms. If eligible, the benefits

available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

This position is anticipated to close on Jul 10, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email ... for other accommodation options.