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IRT Systems Lead
2 months ago
Position Title:
Interactive Response Technology (IRT) Lead
Location:
Collegeville, PA
Employment Type:
Full-time Contract
Overview
Joulé is seeking an experienced IRT professional with a minimum of 9 years in the field, capable of providing on-site support. The ideal candidate will offer technical knowledge, facilitate cross-departmental collaboration, and contribute to system design teams to maintain uniformity in standards and strategic decision-making.
The role involves reviewing ongoing studies from acquisitions to pinpoint necessary IRT functionalities and procedural adjustments for seamless integration into the company’s IGOT team.
Preference will be given to candidates with prior experience in GMP, GCP, or regulatory audits. If you meet the qualifications outlined below, we encourage you to consider this opportunity.
Key Responsibilities:
- Act as a strategic partner and primary contact for protocol evaluation and IRT system selection for designated studies.
- Collaborate with the IRT vendor to gather and document system requirements for new and modified studies in conjunction with the SCL, CRP, and clinical teams.
- Develop and implement UAT test plans where applicable.
- Work alongside the IRT vendor to produce IRT support documents and presentation materials for clinical teams and investigator site staff.
- Contribute to the development of SOPs and processes, and assist in quality investigations and CAPA resolutions.
- Serve as the subject matter expert for regulatory inspections or Clinical Supply Teams for assigned studies.
Qualifications:
A Bachelor’s degree in computer science, life sciences, or a business-related field is required, with an advanced degree preferred. Candidates must be eligible to work in the U.S.
Experience Required:
9+ years in IRT, clinical supply, and/or business analysis.
Familiarity with clinical data and IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards.
Experience in a GMP/GCP environment and with regulatory audit teams is essential.
Continuous improvement certifications such as PMP, CBAP, AIM, or Lean Six Sigma Green Belt/Black Belt are advantageous.
Benefits:
System One provides eligible employees with a variety of health and welfare benefits, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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