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.

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 of experience in clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation
• 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.

This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs