RTSM Solutions Architect - New Build/Amendments

4G Clinical; Wellesley (MA); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, dental, and vision benefits

Unlimited Vacation Days for Salaried F

FSA and Dependent Care Accounts

Company Paid Disability and Life

Job summary

4G Clinical LLC. is seeking a Client Services Lead to drive system implementation and product development for RTSM/IRT solutions.

The role will oversee configuration changes to the PRANCER technology, manage project scope, and partner with Support, Validation, and Integration teams to ensure successful client deployments. The ideal candidate brings 5+ years in clinical research, a strong grasp of GCP/21 CFR Part 11, and experience delivering high-quality, validated deployments in a fast-paced

Qualifications

• Minimum 5 years in clinical research, especially clinical supplies ops, RTSM/IRT services delivery
• Knowledge of US FDA GCP and ICH GCP regulations, 21 CFR Part 11 and EU Annex 11 is essential

Responsibilities

• Expert implementation of configurations to PRANCER technology.
• Define and manage project scope with timelines and high quality deliverables.
• Partner with Support Leads to manage client relationships and ensure successful implementations.
• Provide change design consultation during discovery phase.
• Coordinate validation with the Validation team to ensure thorough testing.
• Work with Integration team to define and implement required changes.
• Prepare technical environments for client use including UAT and production changes.
• Identify opportunities for product enhancements with the Product Development team.

Skills

5+ years in clinical research

GCP knowledge

21 CFR Part 11

electronic records; electronic signatu

Education

Bachelor's degree in life sciences, supply chain, or IT

Tools

RTSM/IRT systems

Job 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 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.

Summary

4G Clinical is honored to be part of Fast Company's 2020 Best Workplaces for Innovators list, citing businesses and organizations that demonstrate a deep commitment to encouraging innovation at all levels. 4G Clinical came in at #8 for its dedication to building a culture that fuels innovation, curiosity, and the spirit of experimentation in all facets of the business from product development and brand to services and staffing. We were also voted one of the 2018 Best Places in Health Care & Biopharma by Great Place to Work® and FORTUNE.

About Us

4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solutions utilizing natural language processing (NLP) to accelerate clinical trials. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia.

For U.S.-based candidates, we offer compelling benefits to our employees, including:

• Health, dental, and vision benefits
• Unlimited Vacation Days for Salaried Full-time Employees
• FSA and Dependent Care Accounts
• Company Paid Disability and Life Insurance
• Generous 401k program
• Paid sabbatical program

4G Clinical is proud to be an Equal Opportunity Employer, and it is foundational to how we recruit and hire our talented team. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law.