Job Abstract

• Serve as a strategic partner and POC for protocol assessment and IRT system selection for assigned studies.
\r• 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.
\r• Write and execute UAT test plans where UAT is employed.
\r• Work with the IRT vendor to create IRT supportive documents and investigator meeting slides for clinical teams and investigator site personnel.
\r• Train partnering lines on the system functionality applicable to their study.
\r• Provide technical expertise and knowledge sharing across engagement and system design teams to ensure consistency in standards, design and strategic decision making.
\r• Review 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.
\r• Contribute to or lead cross line initiatives and quality investigations
\r• Provide input into SOPs and process development and aid in quality investigations and CAPA resolution.
\r• Serve as the IRT representative on Clinical Supply Teams for assigned studies.
\r• Serve as subject matter expert during regulatory inspections for assigned studies.
\r• Assist in the oversight and onboarding of new vendors and active studies coming into company’s IGOT team through acquisition.

• BA/BS, in computer science, life science, or business field required in biopharma industry. Advanced degree desired.
\r• Minimum 9+ years of industry experience with IRT, clinical supply, and/or business analysis desired
\r• Understanding of the nature of clinical data and concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards
\r• Knowledge and experience working in a GMP / GCP environment and with regulatory audit teams
\r• Project management and/or continuous improvement experience or certification such as PMP, CBAP, AIM or Lean Six Sigma Green Belt/Black Belt a plus
\r• Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required
\r• Comfortable working with a global team, partners and customers in a change agile environment
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\rPHYSICAL/MENTAL REQUIREMENTS
\r• Database query, business analysis and technical writing skills a plus
\r• Experience participating in root cause analysis using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram
\r• Experience with business analysis and/or project management tools a plus (ex. MS Project, MS Visio, HP Quality Center, or any other requirements visualization and analysis tools)
\r• Comfort with facilitating requirements elicitation sessions, modeling requirements, and negotiation of business needs as they apply to system functionality.
\r• Ability to represent IRT function in a high-pressure environment (e.g., during regulatory inspections).
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\rHard Skills:
\r• IRT Skills (build and support systems)*****
\r• Working with Vendors oversight
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\rPreferred Skills:
\r• People skills