Job Title: Interactive Response Technology (IRT) Lead

Location: Collegeville, PA

Hours/Schedule: Full-time

Type: Contract

Overview

Joule has an opening for an IRT professional with at least 9 years of experience that is able to work onsite based in Collegeville, PA. You will p rovid e technical expertise, cross-functional engagement, and system design teams to ensure consistency in standards, design and strategic decision making.

Review of ongoing studies coming in through acquisition to identify IRT functionality and procedural changes that need to be implemented to integrate the study into company's IGOT team for support will be required. Candidates with prior GMP, GCP, or regulatory audit experience will have preference; if you meet the below qualifications, please apply!

Responsibilities

• Serve as a strategic partner and POC for protocol assessment and IRT system selection for assigned studies.

• Work with the IRT vendor to elicit and document system requirements for new and amended studies in partnership with the SCL, CRP and clinical team.

• Write and execute UAT test plans where UAT is employed.

• Work with the IRT vendor to create IRT supportive documents and investigator meeting slides for clinical teams and investigator site personnel.

• Provide input into SOPs and process development and aid in quality investigations and CAPA resolution.

• Serve as the SME for regulatory inspections OR Clinical Supply Teams for assigned studies.

  Requirements

• BA/BS, in computer science, life science, or business field required in biopharma industry. Advanced degree desired.

• Must be eligible to work in the U.S.

• 9+ years of: IRT, clinical supply, and/or business analysis experience

• Understanding of the nature of clinical data and concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards

• Experience working in a GMP / GCP environment and with regulatory audit teams

• Continuous improvement certification such as PMP, CBAP, AIM or Lean Six Sigma Green Belt/Black Belt a plus

  Benefits

  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.