Software Integrations Lead

4G Clinical LLC.; Wellesley (MA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health benefits

Unlimited vacation

401k plan

Sabbatical program

Life Insurance

FSA

Job summary

4G Clinical LLC. in the US East region seeks an Integration Project Lead to guide client integrations of Prancer RTSM/Admin systems. You will manage projects, coordinate with cross-functional teams, and ensure timely delivery while maintaining high-quality standards.

Ideal candidates have 3+ years in clinical research or 7+ years in system implementations, plus knowledge of GCP/21 CFR Part 11. The role emphasizes client engagement, testing, and alignment with study needs.

Qualifications

• 3+ years in clinical research with RTSM/IRT and eClinical systems.
• Experience leading cross-functional project teams as project lead.
• Knowledge of FDA GCP, ICH GCP, 21 CFR Part 11; EU Annex 11 a plus.

Responsibilities

• Primary client engagement contact for integration projects.
• Lead client meetings and requirements discussions with support from the Integrations Analyst.
• Maintain knowledge of Prancer RTSM/Admin and ensure integration design aligns with study design.
• Log, track and drive resolution of functional and technical issues pre- and post go-live.
• Ensure adherence to deliverables and milestones defined in SOPs/WIs.
• Drive project activities, including study testing and UAT.

Skills

Client engagement

Project management

eClinical systems

RTSM/IRT

Education

Bachelor's degree

Life science / IT background

Tools

Prancer RTSM

Job description

Preferred Location is US East Join 4G Clinical as an Integration Project Lead and lead client integration projects, ensuring smooth implementation of our Prancer RTSM/Admin systems. This role involves client engagement, managing project activities, and resolving issues, all while maintaining high-quality standards. Ideal candidates have experience in clinical supplies operations, eClinical systems, and project management.

Brief Description

Preferred Location is US East Join 4G Clinical as an Integration Project Lead and lead client integration projects, ensuring smooth implementation of our Prancer RTSM/Admin systems. This role involves client engagement, managing project activities, and resolving issues, all while maintaining high-quality standards. Ideal candidates have experience in clinical supplies operations, eClinical systems, and project management.

Key Accountabilities of the Integrations Project Lead include the following:

• Primary Client engagement contact for Integration projects
• Leading client meetings and requirements discussions with support from the Integrations Analyst
• Maintain knowledge of Prancer RTSM/Admin and serve as the SME ensuring integration design is compatible with Prancer study design
• Logs, tracks and drives resolution of functional and technical issues discovered during implementation and prior to go-live
• Ensures adherence to required deliverables and milestones as defined in applicable SOP/WIs
• Drives project activities, including study testing and UAT

Requirements

• The position requires a minimum of 3 years of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems and integrations implementation, or over 7 years of relevant system implementation experience in related industry.
• Software implementation and testing experience required in clinical research or a supply chain related industry. Project management experience working with cross‑functional business and technical teams as project lead is required.
• Knowledge of 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 is a plus.

Education And/or Certification Requirements

The candidate must possess at minimum a bachelor’s degree in a life science, supply chain management, or information technology field, or 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
• Global mental health benefit
• 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.