Build and deliver a study specific Randomization and Trial Supply Management (RTSM), i.e. IRT/IxRS, solution for the client, be in an interface role with overall responsibility for project delivery, become a system expert to perform the study build with configuration, work with clients to understand their needs and work with the development team to address potential product gaps.
Additionally, support sales as needed, either on site or remotely, and contribute internally to making the business a young, cutting edge technology company successful.
- Expert implementation of client RTSM (IRT/IxRS) applications to enable client start-up targets
- Primary client engagement contact, responsible for the health of the client relationship working with clinical study teams to establish RTSM requirements and deliver robust RTMS delivery and oversight for study operations;
- Work with product development to ensure study level applications are designed, configured, customized and tested to deliver a high quality, validated system to clients.
- Expert in company’s clinical technology; writing client study requirements using the system’s Smart Specification Editor, facilitating client and technical team review and approval, identifying additional client specific requirements and configuring final study application with the product’s specification interpreter;
- Responsible for project level validation to ensure study application is developed; testing and deployed as per company’s clinical SOPs;
- Identify study customizations required, if any, to ensure that an impact assessment can be properly conducted as per company’s clinical SOPs;
- Use the product’s specification editor logs and testing results to identify any gaps between the study requirements and the system capabilities. Coordinate with the development team to address those gaps by adapting the specifications, enhancing the system capabilities, or customizing the study/sponsor system;
- Develop client and site system training manuals and deliver study training for clinical team;
- Prepare the system for UAT and PROD, in coordination with the development team as necessary;
- Coordinate efforts towards data uploads (users, sites, randomization lists etc.) in the different environments;
- Coordinate efforts towards system integration with 3rd parties such as CTMS, EDCs, CROs/shippers, etc.
- Work with client clinical supplies leads to understand their supply strategies, train them properly on the use of the product’s integrated forecasting capabilities and provide expert consultation for supplies personal in establishing their initial supply settings.
- Primary client contact for day to day operations in support of RTSM applications;
- Develop, implement and oversee client communication plans, including service level agreements data management and support procedures, as per company’s clinical SOPs;
- Consult with client clinical supplies leads to enable clinical supplies operations, supporting exception management and forecasting/reforecasting needs;
- Customer Support point of escalation for any system or support issues where required; develop training materials and train Customer Support staff on study application support procedures and client standards;
- Monitor study issues for trends to enhancement opportunities or additional training needs;
- Participate in client audits.
- Identify operational business needs and collaborate with product development to influence RTSM product feature development, prioritization and strategy to ensure that the product meets client capability needs, improve the system’s efficiency and user-friendliness.
Qualifications and Experience:
- Minimum of 4 years in experience in the clinical research field, particularly in clinical supplies, clinical operations and/or RTSM/IRT services delivery and eClinical systems implementation;
- Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11, and associated regulatory guidance documents;
- Experience with IRT/RTSM development as well as clinical supplies forecasting and management is highly desired;
- Supply chain certification or experience is a plus.
- Technical experience and interest is a must; having lead or been involved in system development projects, writing requirements and test cases, is a plus;
- Experience working with agile development methodology is a plus;
- Fluent in both written and spoken English; German or French knowledge is a strong preference;
- Relevant working/residency permit or Swiss/EU-Citizenship required.
Our client, a Swiss biopharmaceutical company, is looking for an IRT Expert for a permanent role based in the Basel area, Switzerland. The ideal candidate should have previous experience in IRT/IxRS and client clinical supplies leads in the pharmaceutical industry or CRO.
Please contact us directly for more details at firstname.lastname@example.org