Overview
THE COMPANY
PHASTAR is a multiple award-winning, data focused CRO specialising in providing statistics, programming, data management and data science to the pharmaceutical, biotechnology and medical device industries. With offices across the UK, US, Germany, Kenya, Australia and Japan, PHASTAR is the second largest specialised 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.
THE ROLE
Due to global expansion of PHASTAR’s data operations group, we have a senior data management position available to work embedded within the Sponsor site on the FSP model.
Responsibilities
- Provide oversight of all clinical data management activities including database design, study set-up and reporting
- Project lead assigned studies; provide guidance to team members, coordinate data processing activities, ensure clinical databases are correct, prioritise quality in all activities, work with the study statistician and project manager regarding resourcing, timelines, budgets and deliverables
- Actively participate at project kick-off and clinical trial team meetings, ensuring appropriate levels of support and communication, and the completion of assigned actions within required timeframe
- Review draft protocols and CRFs/eCRFs for potential data collection, database structure or data entry problems and provide feedback to the project team
- Design/review eCRF layout ensuring consistency with protocol requirements
- Create/test the study database according to the eCRF specifications
- Design/review/program/test edit checks
- Assist/lead coding of medical terms
- Implement CDASH standards and produce/review CRF specifications
- Provide exceptional customer service to clients
- Provide support for Data Safety Monitoring Board and all other vendors including training of Investigators, site staff and the client’s internal teams
- Ensure audit readiness and involvement in the CAPA process
Qualifications
- Life Science degree, nursing qualification or equivalent experience
- Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation
- Previous project leadership experience
- Experience of data management software systems (preferably Medidata Rave and Medrio)
- Knowledge of coding dictionaries including MedDRA and WHODrug Familiarity
- Technical expertise, i.e. knowledgeable on CDASH approach and SDTM
- Excellent written and verbal English
