Client Services Lead – IRT/IxRS

Inactive

Reference Number: 895824-W
Type of placement: Permanent
Location: Switzerland, North West

Introduction:

Our client, a Swiss biopharmaceutical company, is looking for a Client Services Lead – IRT/IxRS for a permanent role based in the Basel area, Switzerland. The ideal candidate should have previous experience implementing Randomization and Trial Supply Management systems (IRT/IxRS) for international pharmaceutical companies.

Main Responsibilities:

  • 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
  • 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
  • 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
  • Experience with IRT/RTSM development as well as clinical supplies forecasting and management is highly desired
  • 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
  • Technical experience and interest is a must; having lead or been involved in system development projects, writing requirements and test cases, 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