The IRT Global Oversight Team (IGOT) is a well-established high performing team within Pfizer's Global Clinical Supply unit striving to deliver best in class Interactive Response Technology (IRT) systems providing randomization and drug management capabilities in support of Pfizer's dynamic investigational product portfolio. The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our internal and vendor IRT solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes.
The IRT Lead is a new 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 Pfizer’s new internal IRT system (Impala 2.0). The implementation of this new 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.
For internal IRT solutions (e.g., Impala 2.0), he or she will elicit additional protocol requirements from the clinical team, then partner with the IGOT Design and Support teams to ensure the protocol is configured, test scripts are complete and appropriate, and deployed to production successfully upon their successful completion of User Acceptance Testing (UAT).
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.
The IRT Lead will be therapeutically aligned where feasible, 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.
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.
- Serve as a strategic partner and POC for protocol assessment and IRT system selection for assigned studies.
- 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.
- Create IRT supportive documents and deliver investigator meeting slides to 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.
- 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.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- 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 environment.
- 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).
Other Job Details:
- Eligible for Employee Referral Bonus: YES
- Eligible for Relocation: NO
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