Clinical RTSM/IRT Integration Test Engineer

4G Clinical LLC.

Wellesley (MA)

On-site

USD 90,000 - 120,000

Full time

3 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

Health, dental, and vision benefits

Unlimited vacation for salaried full‑n

FSA and Dependent Care Accounts

Company paid disability and life

Global mental health benefit

Generous 401k program

Paid sabbatical

Job summary

4G Clinical LLC is seeking a detail-oriented tester to validate our integration solutions supporting clinical studies. You will collaborate with Integrations Leads to ensure high-quality, validated integrations delivered to clients, and develop study-specific test plans and cases.

Ideal candidates have 2+ years in clinical research, familiarity with GCP/21 CFR Part 11, and experience with IRT/RTSM or agile environments. This role involves following SOPs and participating in client audits.

Qualifications

Minimum 2 years’ experience in clinical research, RTSM/IRT services delivery and eClinical systems implementation.
Knowledge of US FDA GCP and ICH GCP regulations, 21 CFR Part 11 and EU Annex 11.
Software testing experience is a plus.
Experience with IRT/RTSM and Agile development is a plus.

Responsibilities

Testing of Company’s proprietary Integration solutions in support of the client’s study.
Collaborate with Integrations Leads to ensure integration builds are tested appropriately to deliver a high quality, validated integration to clients.
Develop study-specific integration validation plans, test strategies and test cases.
Execute integrations testing, following 4G Clinical SOPs.
Participate in client audits.