This role is remote and can be worked by any suitable person located on the East or West coast.
RESPONSIBILITIES
Key Accountabilities of the Client Services Lead include the following:
System Implementation
Expert implementation of client RTSM 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 and Quality Analysts to ensure study level applications are designed, configured, customized and tested to deliver a high quality, validated system to clients.
- Become an expert in the software 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 software specification interpreter.
- Responsible for project level validation to ensure study application is developed, testing and deployed as per the company SOPs.
- Identify study customizations required, if any, to ensure that an impact assessment can be properly conducted as per the company SOPs.
- Use the software 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 systems integrated forecasting capabilities and provide expert consultation for supplies personal in establishing their initial supply settings.
System Operations
• 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 the company 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.
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.
REQUIRED EXPERIENCE
The position requires a minimum of 5 years' (10 for senior) in 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.
EDUCATION AND/OR CERTIFICATION REQUIREMENTS
The candidate must possess at minimum a bachelor’s degree in a life sciences, supply chain management, or information technology field, or 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, 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