Job Description
THE COMPANYPHASTAR is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, PHASTAR is the second largest specialized biometrics provider globally, and the largest in the UK.Our unique approach to data analysis, “The PHASTAR Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.WHY PHASTARAccredited as an outstanding company to work for, PHASTAR is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.What’s more, when you join our team, PHASTAR will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you’ll also be helping to save the planet!THE ROLEDemand for our Functional Service Provision is growing, and we are looking for an EDC Engineer to join our highly-skilled and reputable FSP team.This is a fantastic 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 pharmaceutical environment.Key Responsibilities:Create eCRF specifications, design, develop and validate clinical trial setup processCreate edit check specifications and setup edit checks at trial levelCreate and implement UAT scripts to test the setup of the clinical studySetup different instances of study URL (e.g.,: UAT, production, testing etc.)Setup and configure user accounts for study teamsSetup and manage blinded and unblinded study configurationsSetup, 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 systemsWork closely with EDC vendors regarding any tool related issues in the systemPrepare, test and implement post production changes as per study needsArchive and retire the study URL after database lockLead technology vendor oversight activities, ensure established milestones are met with the highest degree of qualityEstablish and support business process SOPs, technology standards and governance modelsOversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizationsBe a primary change agent to ensure adoption of new capabilities and business processEssential Skills and Experience Required:4+ years of industry/life-science related experienceVeeva and Medidata Rave experienceExcellent written and verbal communication skillsWorks well under instruction as well as shows initiativeAPPLY NOWWith the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in Canada or the US, as this role can be carried out remotely.***PHASTAR does not accept any CVs received from recruitment agencies. In the event that speculative CVs are submitted by recruitment agencies, PHASTAR reserves the right to contact these candidates directly and consider them for current/future vacancies without any financial obligation to the recruitment agency in question. This applies to any CVs sent directly to any PHASTAR employee.***