Overview
About Phastar
Phastar brings data to life! We are an award-winning specialist biometrics contract research organization (CRO) that works with pharmaceutical, biotechnology and medical device companies to provide statistical consulting, analysis and reporting, data management, and data science services.
Our unique approach to data analysis, “The PHASTAR Discipline”, has gained us a reputation for outstanding quality. With this as our core focus, we’re looking for a talented individual who shares our passion for quality and technical expertise to join our team…could this be you?!
Why Phastar
Phastar is a company that cares. We strive to be the premier biometrics provider to work with, and to work for, and we take our responsibility to do our part for the environment and our community seriously.
Our pro bono scheme provides charities access to our biometrics experts at no cost; we source sustainable products to reduce our carbon footprint and, when you join our team, we will plant a tree in your honour as part of our rewilding project. Learn more about our ESG initiatives at phastar.com/cares.
Caring for YOU
YOUR career, YOUR work/life balance, YOUR PHASTAR experience.
- Total flexibility – working hours that work for YOU.
- Remote, office or hybrid – a working arrangement that works for YOU.
- Culture of learning – continuously develop YOUR knowledge and share YOUR expertise with others.
- Career Path - tailored to YOUR strengths and aspirations.
- Regular well-being checks – to ensure you get the support you need.
- Fun, friendly working environment – experience PHASTAR’s famous social events throughout the year.
Responsibilities
THE ROLE
Demand for our Functional Service Provision is growing, and we’re looking for talented individuals who share our passion for quality and technical expertise to join our FSP team. All positions can be remote. As a EDC Engineer working within FSP, you will be fully integrated into our sponsor’s team as a key contributor, providing that partner with hands-on technical expertise. Our FSP positions provide the unique opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a sponsor’s pharmaceutical environment.
- Create eCRF specifications, design, develop and validate clinical trial setup process
- Create edit check specifications and setup edit checks at trial level
- Create and implement UAT scripts to test the setup of the clinical study
- Setup different instances of study URL(eg: UAT, production, testing etc.,)
- Setup and configure user accounts for study teams
- Setup and manage blinded and unblinded study configurations
- Be the SME for all database related activities
- Setup, configure, validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.,
- Knowledge of creating custom functions within EDC systems
- Work closely with EDC vendors regarding any tool related issues in the system
- Ability to troubleshoot database setup as per study needs
- Prepare, test and implement post production changes as per study needs
- Archive and retire the study URL after database lock
- Partner with appropriate team members to establish technology standards and governance models
- Establish and support business process SOPs.
- Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations
- Be a primary change agent to ensure adoption of new capabilities and business process
- Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.
- Work with leaders to resolve issues affecting the delivery of clinical trials
- Collaborate with standards team in creating standard CRF libraries for study level consumption
- Work closely with data engineers and data management programmers at study level integration and delivery
- Lead technology vendor oversight activities.
- Be a process expert for operational and oversight models.
- Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.
- Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents
- Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.
- Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables.
- Adaptable to new ways of working using technology to accelerate clinical trial setup
Qualifications
The skills and experience you’ll bring to the role…
