Overview
THE COMPANY
Phastar 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 PHASTAR
Accredited 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, 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 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.
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.
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
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
APPLY NOW
With 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, 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 in China.
Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.
Important notice to Employment businesses/Agencies
Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
