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Robert Half Interactive Response Technology (IRT) Lead in Collegeville, Pennsylvania

Description

We are inviting applications for an Interactive Response Technology (IRT) Lead role based in Collegeville, Pennsylvania, United States. This role is part of the IRT Global Oversight Team within the pharmaceutical industry, providing randomization and drug management capabilities in support of our investigational product portfolio. The Software Engineer will be a strategic partner and single point of accountability for protocol assessments, system deployments, and resupply settings guidance for our IRT systems developed with external vendors.

Responsibilities:

• Serve as a strategic partner and single point of accountability to partner lines for protocol assessments, requirements elicitation, and system deployments

• Conduct preliminary protocol assessments in collaboration with Supply Chain Leads, Clinical Research Pharmacists, and other clinical team members to determine the most effective IRT strategy

• Present key preliminary requirements and IRT system recommendations to the IRT Protocol Assessment Group for final determination

• Elicit additional protocol requirements from the clinical team and partner with IRT vendors to ensure the IRT system is programmed according to the protocol

• Ensure test scripts are complete and accurate, and execute User Acceptance Testing in order to successfully deploy the system into production

• Serve as a member of the Clinical Supply Team and as the point of contact throughout the life of the study

• Provide guidance on IRT resupply settings and any requisite system amendments for ongoing studies

• Integrate ongoing studies that have come into the company through acquisitions, aligning them with company standards and processes

• Identify IRT functionality and processes at the IRT vendor that need to be modified to align with company processes and work with the vendor and study team to implement these changes

• Partner with IGOT management for quality investigations, CAPA commitments, and continuous improvements, SOP review and revision activities, support regulatory inspections, and limited duration teams.

Requirements

• BA/BS in computer science life science or business field required.

• 9 years of industry experience with IRT clinical supply and/or business analysis desired.

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

• Proficiency in software engineering and related technical skills.

• Strong understanding and experience with Agile Scrum methodologies.

• Excellent communication and customer service skills.

• Ability to design, review and implement software systems.

• Demonstrated experience in planning processes and project management.

• Strong written skills for documentation purposes.

• Experience in quality assurance and optimization of software systems.

• Ability to provide workstation support and handle production tasks.

• Experience working with vendors and managing onboarding processes.

• Proficiency in English language is required for effective communication.

• Negotiation skills and experience with implementation of software systems.

• Experience with integration of systems and working with partners.

• Ability to execute tasks efficiently and work collaboratively in a team.

• Knowledge of configuration management and business analysis.

• Strong understanding of clinical trial operations.

• Ability to provide oversight on software projects.

• All applicants must be legally authorized to work in the country where the job is located.

• Willingness to continue learning and improving technical skills.

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