Responsibilities

The Client Services Lead is responsible for the following:

System Implementation

• Expert implementation of client RTSM (Randomization and Trial Supply Management) applications to enable client start-up targets.
• Primary client engagement contact during initial system build, responsible for the health of the client relationship, working with clinical study teams to establish RTSM requirements and deliver robust RTSM delivery and oversight for study operations.
  
• Work with product development and Quality Analysts to ensure study level applications are designed, configured, customized and tested to deliver a high quality, validated system to clients.
• Expert in 4G Clinical’s Prancer RTSM 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 Prancer’s specification interpreter.
• Responsible for project level validation to ensure study application is developed, tested and deployed as per 4G Clinical SOPs
• Identify study customizations required, if any, to ensure that an impact assessment can be properly conducted as per 4G Clinical SOPs.
• Use 4G technical tools and analysis of 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 Prancer system for UAT and PROD, in coordination with the development team as necessary.
• Coordinate efforts regarding data uploads (users, sites, randomization lists, etc.) in the various environments.
• Coordinate efforts regarding 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 Prancer’s integrated forecasting capabilities and provide expert consultation for supplies personnel in establishing their initial supply settings.

System Operations

• Primary client contact during initial build of RTSM application
• Coordinate development of study data management plan and internal support reference materials
• Internal escalation contact for Customer Support for any system or support issues where required
• Participate in client audits and internal CAPA process as needed

Product Development

• 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.

Development and Process Management

• Support maintenance and development of Client Standards as needed; and ensure adherence to Standards during study implementation

Required Experience

A minimum of 5 years (10 for senior) of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation is preferred. The following skills are essential: 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.

Education and/or Certification Requirements

The candidate should possess at minimum a bachelor’s degree in a life sciences, supply chain management, or information technology field, or have equivalent experience.

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, committed to highest quality deliverables. Excellent verbal and written communication skills.
• Up to 25% business travel, namely for on-site client visits in support of sales opportunities, client specification development, client User Acceptance Testing and industry conferences.