Our client is an exciting scale up Software Solutions Provider working at the cutting edge of clinical trials technology. This newly created permanent role will be a fantastic opportunity to become part of a company with an aspirational culture, a defined career path and a leadership team who are open to new ideas and like to say yes! We are looking for a competent individual with excellent RTSM/ IRT experience gained in a clinical operations, service delivery or implementation environment.
You will be part of a growing team of individuals who support client implementation of RTSM software from setup through to closeout of the client study. This will see you involved in business process assessments, specification development, integration oversight, and once implemented assume responsibility for the client via study progress tracking, advice on best practice, issue escalation and system customization.
Your hard work will be rewarded with an outstanding salary, brilliant benefits and the chance to build your career in a fascinating and innovative sector.
This position can be based in Dublin Ireland, Basel Switzerland or Amsterdam Netherlands. Remote home working for the right person is also considered.
- Degree in Life Sciences, Supply Chain Management or IT field or equivalent knowledge
- Several years’ experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation.
- Knowledge 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.
Other Skills / Requirements:
- Clinical supplies forecasting and management experience is highly desired.
- Supply chain certification or experience is a plus.
- Experience with IRT/RTSM and clinical supplies forecasting/simulation tools is a plus.
- Experience working with agile development methodology is a plus.
- Leadership Competencies; Client focused, solutions focused, proactive, responsive, organized, highest quality deliverables. Excellent verbal and written communication skills.