Education and Work Experience:

• 2-4 years of experience in clinical supplies, clinical research, or database design & development
• B.A./B.S. in biology, life sciences, computer science, or related field
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

Knowledge, Skills, and Abilities:

• Demonstrated knowledge of IVRS development processes.
• High level understanding of clinical supply chain within the pharmaceutical industry.
• Knowledge of databases, structure, & corresponding tools used to manage, extract, & report data.
• Working knowledge of clinical development and statistical concepts.
• Effective written and verbal communication skills.
• Ability to organize and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to Sponsor and external to Sponsor.
• Average proficiency with Microsoft applications (Word, Excel, PowerPoint, Project).
• Working knowledge of regulatory requirements (e.g., GMP), quality procedures and SOP execution.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

• Provide end-to-end IVRS support to clinical project teams. 
• Execute IVRS development process from kickoff to system go-live, ongoing system change control, and system closeout.
• Work with the internal stakeholders and IVR vendors to gather/develop/define study-specific IVR requirements, develop implementation plans, and create / enforce the use of IVRS standards.
• Ensures adherence to IVRS standards, reviews study team business case proposals, and provides final go / no-go decision regarding requests to utilize custom functionality.
• Manage vendor performance and relationship(s) at the study level.
• May perform root cause analysis and identification of corrective/preventative actions, serving as a point of escalation for vendor issues.
• Ensure vendor system development processes align with client's Quality and System Life Cycle expectations.
• Monitors and analyzes system change requests, and identifies corrective actions for utilization of standards.
• May provide support in the following areas:
• data transfer issue resolution between IVRS vendors and shipping depots in support of shipping processes, DOF/ERP specifications, and issue resolution.
• lock & transfer of allocation schedules to IVRS vendors, the requirement document approval process, or the provision of site & client's user information to IVRS vendors.
• development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documents.
• process improvement activities.
• training and education for stakeholders including developing or assisting in the development of reference and/or training material; may provide cross-functional internal and external communication as needed.