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
- Option Grants
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.
Requires 3+ years in clinical research, clinical supplies, eClinical systems, or integrations, or 7+ years in related implementation; project leadership, testing, and a bachelor's degree required.
Key Responsibilities
- engaging clients
- leading meetings
- resolving issues
Skills & Tools
Prancer RTSM/Admin, Electronic Records; Electronic Signatures regulation (21 CFR Part 11), NLP
Job Details
- Category: Project and Program Management
- Seniority: Mid Level
- Commitment: Full Time
- Workplace: Remote — Wellesley or United States
- Languages: English
Benefits
- 401k matching
- Generous paid time off
- Retirement plan
About 4G Clinical
A life sciences software company providing cloud-based randomization and trial supply management solutions. — Industry: Research and Development