Software Integrations Lead

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.

4G Clinical is honored to be part of Fast Company's 2020 Best Workplaces for Innovators list and was voted one of the 2018 Best Places in Health Care & Biopharma by Great Place to Work® and FORTUNE.

About the Role

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. Preferred location is US East.

Responsibilities

• Serve as the 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 serve as the subject matter expert (SME) to ensure integration design is compatible with Prancer study design.
• Log, track, and drive resolution of functional and technical issues discovered during implementation and prior to go-live.
• Ensure adherence to required deliverables and milestones as defined in applicable SOPs and work instructions (WIs).
• Drive project activities, including study testing and user acceptance testing (UAT).

Requirements

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

Knowledge of US FDA Good Clinical Practice (GCP), International Conference on Harmonization (ICH) GCP regulations, Electronic Records and Electronic Signatures regulation (21 CFR Part 11), and EU Annex 11 is a plus.

Qualifications

The candidate must possess at minimum a bachelor’s degree in a life science, supply chain management, or information technology field, or equivalent experience.

Benefits

• 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.
• Option grants.