Overview
ABOUT PHASTAR
PHASTAR is a multiple award-winning global biometric Contract Research Organization (CRO). 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, Kenya, Australia, India, China and Japan, PHASTAR is the second largest specialized biometrics provider globally, and the largest in the UK.
THE ROLE
Demand for our Functional Service Provision is growing, and we are looking for an EDC Engineer with Veeva experience to be fully integrated into our sponsor’s data management team.
Responsibilities
- Create eCRF specifications, design, develop and validate clinical trial setup process
- Using Veeva EDC Systems
- 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
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
- 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
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.
Qualifications
- University or college degree in Life Sciences, Mathematics, Computer Science or equivalent degree
- At least 5 years’ experience in clinical database programming, setup of clinical databases and eCRF design, edit checks, Custom Function and Migration, gained in the pharmaceutical industry, CRO or Life science related industry
- Certification in Medidata Rave EDC and Veeva
- Strong knowledge of C#
- Knowledge of SAS
- Knowledge of clinical data capture software or relational databases as applied to clinical trials
- Knowledge and experience of the implementation of CDISC CDASH and SDTM Standards