Randstad

He or she will perform a preliminary protocol assessment with the Supply Chain Lead (SCL), Clinical Research Pharmacist (CRP) and clinical team members (e.g., clinician, biostatistician) to determine the most effective IRT strategy for clinical customer, investigator site, Global Clinical Supply, and ultimately for the patient.. He or she will work to elicit additional protocol requirements from the clinical team, then partner with the IRT vendor to ensure the IRT system is programmed according to the protocol, test scripts are complete and accurate, and execute User Acceptance Testing (UAT) in order to successfully deploy the system into production.. The IRT Lead will also partner with IGOT management for quality investigations, CAPA commitments and continuous improvements, SOP review and revision activities, support regulatory inspections, and limited duration teams where appropriate.. Project management and/or continuous improvement experience or certification such as PMP, CBAP, AIM or Lean Six Sigma Green Belt/Black Belt a plus. People skills skills: SOP, CAPA, GCP (Good Clinical Practice), PMP, GMP (Good Manufacturing Practice)

first shift

job summary:  The IRT Lead is a role within the Engagement function in IGOT that will serve as a strategic partner and single point of accountability to partner lines for protocol assessments, requirements elicitation, system deployments, and resupply settings guidance for company’s IRT system developed with external vendors. The implementation of this role is intended to strengthen key interfaces within assigned therapeutic areas, streamline processes and increase agility.The IRT Lead will be assigned when it is determined that an IRT system may be needed at the draft protocol stage. He or she will perform a preliminary protocol assessment with the Supply Chain Lead (SCL), Clinical Research Pharmacist (CRP) and clinical team members (e.g., clinician, biostatistician) to determine the most effective IRT strategy for clinical customer, investigator site, Global Clinical Supply, and ultimately for the patient. The IRT Lead will present the key preliminary requirements and IRT system recommendations to the IRT Protocol Assessment Group for final determination.He or she will work to elicit additional protocol requirements from the clinical team, then partner with the IRT vendor to ensure the IRT system is programmed according to the protocol, test scripts are complete and accurate, and execute User Acceptance Testing (UAT) in order to successfully deploy the system into production.The IRT Lead will serve as a member of the Clinical Supply Team and as the IGOT POC throughout the life of the study. For ongoing studies, he or she will also be available for guidance on IRT resupply settings and any requisite system amendments.In addition to developing new IRT systems, the IRT Lead would be assigned ongoing studies that have come into company through an acquisition. He or she will work to integrate these studies to align with company standards and work within company’s processes. This will include identifying IRT functionality and processes at the IRT vendor that need to be modified to align with company processes. The IRT Lead would be responsible for working with the vendor and study team to implement this system and/or procedural changes.The IRT Lead will also partner with IGOT management for quality investigations, CAPA commitments and continuous improvements, SOP review and revision activities, support regulatory inspections, and limited duration teams where appropriate.For this position candidates will need to be able to think outside of the box, have excellent communication and analytical thinking skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio. 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.• Train partnering lines on the system functionality applicable to their study.• Provide technical expertise and knowledge sharing across engagement and system design teams to ensure consistency in standards, design and strategic decision making.• 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.• Contribute to or lead cross line initiatives and quality investigations• Provide input into SOPs and process development and aid in quality investigations and CAPA resolution.• Serve as the IRT representative on Clinical Supply Teams for assigned studies.• Serve as subject matter expert during regulatory inspections for assigned studies.• Assist in the oversight and onboarding of new vendors and active studies coming into company’s IGOT team through acquisition. qualifications:  • BA/BS, in computer science, life science, or business field required in biopharma industry. Advanced degree desired.• Minimum 9+ years of industry experience with IRT, clinical supply, and/or business analysis desired• Understanding of the nature of clinical data and concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards• Knowledge and experience working in a GMP / GCP environment and with regulatory audit teams• Project management and/or continuous improvement experience or certification such as PMP, CBAP, AIM or Lean Six Sigma Green Belt/Black Belt a plus• Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required• Comfortable working with a global team, partners and customers in a change agile environmentPHYSICAL/MENTAL REQUIREMENTS• Database query, business analysis and technical writing skills a plus• Experience participating in root cause analysis using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram• 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)• Comfort with facilitating requirements elicitation sessions, modeling requirements, and negotiation of business needs as they apply to system functionality.• Ability to represent IRT function in a high-pressure environment (e.g., during regulatory inspections).Hard Skills:• IRT Skills (build and support systems)*****• Working with Vendors oversightPreferred Skills:• People skills skills:  SOP, CAPA, GCP (Good Clinical Practice), PMP, GMP (Good Manufacturing Practice)

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