5+ years in clinical research, focusing on clinical supplies operations and eClinical systems implementation.
Strong understanding of US FDA Good Clinical Practice (GCP) and ICH GCP regulations.
Familiarity with Electronic Records and Signatures regulation (21 CFR Part 11) and EU Annex 11.
Bachelor's degree in life sciences, supply chain management, or information technology, or equivalent experience.
Proven experience in managing client relationships and project scope.
Responsibilities
Implement configuration changes to 4G Clinical's PRANCER technology with high quality and within timelines.
Define and manage project scope while collaborating with support leads for successful implementation.
Assist in change design consultation during the discovery phase before project initiation.
Work with the Validation team to ensure thorough testing of study changes and risk areas.
Coordinate with the Integration team to define and implement necessary integration changes.
Escalate mid-project scope changes to manage client costs effectively.
Prepare technical environments for internal and client use, including UAT and production.
Benefits
Collaborative work environment with opportunities for professional growth.
Engagement in product development to influence system enhancements.
Exposure to cutting-edge technology in clinical research.
Opportunity to work closely with cross-functional teams.
Full Job Description
Description
Preferred Location is US East or US Central
The Client Services Lead is responsible for the following:
System Implementation
Expert implementation of configuration changes to 4G Clinical's PRANCER technology, including:
Primary responsibility for defining and managing project scope and implementing technical changes within agreed timelines and at the highest quality
Partner with 4G Clinical Support Leads to manage the client relationship and ensure successful project implementation
Provide change design consultation assistance to 4G Clinical Support Leads during 'discovery' phase, prior to formal project request or start-up
Partner with 4G Clinical Validation team to complete project validation, ensuring study changes are fully tested, and related risk areas are regression tested
Partner with 4G Clinical Integration team to ensure that required integration changes are correctly defined, tested and implemented
Escalate mid-project scope changes to 4G Clinical Accounts team to ensure that associated client costs are appropriately assessed and managed
Prepare all technical environments for internal and client use, including client UAT and production change implementation
Ensure that required patient data changes in support of the system changes are defined, scripted and tested
Product Development
Identify opportunities for product enhancements 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
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
Requirements
A minimum of 5 years 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.
About 4G Clinical
4G Clinical is a software company that provides cloud-based solutions for clinical trials. The company's platform, Prancer, uses natural language processing and machine learning to automate the design, randomization, and supply chain management of clinical trials. Prancer also provides real-time analytics and reporting to help clinical trial sponsors make data-driven decisions. 4G Clinical was founded in 2015 and is headquartered in Medford, Massachusetts.
