PHASTAR is a specialist CRO, offering statistical consulting, clinical trial reporting, data management and medical writing services, by providing expert consultants and managing and delivering in-house projects.
If you would like to work with a team of expert statisticians, in a company run and managed by statisticians, where your skills will be valued and nurtured, then our roles may be right for you. PHASTAR are a team of expert statisticians and programmers, working in the medical field.
There are a number of reasons you may wish to join the PHASTAR team:
- Learn from PHASTAR's internal experts and from personnel with specialist PhDs.
- A better way to work: PHASTAR have a unique approach to statistical consulting and data analysis. Our approach ensures high quality consulting and data analysis.
- A relaxed place to work. PHASTAR encourages a hard working but friendly and sociable office environment.
Leadership - Lead Data Manager
- Take responsibility and ownership for data management deliverables on assigned projects
Database Development - CRF/eCRF design
- Design/review CRF/eCRF layout as per protocol requirements
- Create eCRFs within EDC software
- Prepare UAT scripts for cross-function testing.
- Test eCRFs according to UAT scripts
- Design/review edit specifications ensuring concise documentation in the Data Review Conventions
- Create edit check programs within EDC software
- Perform UAT of programmed edit checks
CDISC - CDASH
- Implement CDASH standards.
- Produce and review annotated CRF following the CDASH implementation guide.
Data Base Use
- Oversee or perform the Tracking Receipt/Dispatch of Case Report Forms (CRFs) and other study documents in the study specific database.
- Perform or oversee clinical data management processes
- Perform data review including query production and resolution
- Manage 3rd party data reconciliation and data transfers
Data Handling Manual - Documentation Preparation
- Preparation and review of study specific documents of the Data Handling Manual.
- Ensure all documents are updated and re-issued in accordance with any changes in the study protocol, procedures or processes, or study team
- Set up, maintain and return Trial Master File to sponsor for archive following instructions in supplied
Dictionary Coding - MedDRA , WHODrug
- Assist in coding of drugs and diseases
Study Status reporting
- Weekly/monthly reporting of project status to internal and external project teams
Quality Control (QC) - Data Quality checking
- Prepare/review the QC Plan and ensure QC checks are implemented at the appropriate times.
- Act as the Independent data manager for non-assigned studies and perform QC for as specified in the study specific Quality Control plan
- Work in a team for furthering data capture systems and SOP development
- Take responsibility and ownership for deliverables
- Identify any work-related obstacles and liaise with the Project Team Leader to resolve these
- Actively participate in Study kick-off meetings and other study team meetings.
- Act as Sponsor contact, lead teleconferences and ensure assigned actions are completed within the required timelines
- Work closely with the Sponsor’s study team and 3rd party suppliers, including the Clinical Program Manager, CRA, Drug Safety and Regulatory to meet project deliverables and timelines
- Manage own day-to-day workload to ensure all project goals are met.
- Identify resourcing issues and liaise with Head, Clinical Data Operations to resolve these
- Work closely with the Sponsor's team members.
- Willingness to help others
- Ability to work with others to solve problems, taking the time to see other people’s point of view
- Training and mentoring of junior team members
- Knowledge sharing through attending and presenting at data management and programming forums
- Proactively identify own areas for development/improvement
- Excellent written and verbal English
Attitude and Approach
- An enthusiastic and positive outlook
- A calm and professional manner under all circumstances
- Accept new challenges as learning opportunities
- Flexible and adaptable in your outlook
- Carefully check all your own technical work
- Make the effort to understand new technical issues before jumping in
- Be open to feedback with a view to improve
- Ensure approaches are used that will result in error-free results
- Understanding of how clinical studies work
- Trained in GCP
- Effectively support regulatory and Sponsor audits
- used a database called MediData RAVE,
- Minimum 2 years prior Rave Study Build experience, including programming/configuration of RAVE CRFs, folders, Edit Checks, integrations, migrations, and reports.
- Strong Rave Study Build and administration skills
- Knowledge of SQL preferred
- Help to grow the business
- Prioritise quality in everything that you do. Ensure the principles in the PHASTAR checklist are followed rigorously
- Positively represent the company at external events, presenting posters and talks at external conferences
- Minimum of a BSc in a Life Science Degree
What we offer
- Advancement of your career in an intellectually-stimulating, dynamic, supportive environment
- Variety of projects and clinical trial in a range of therapeutic areas and phases
- Opportunities to get involved in the management
To apply please complete the form below or call +44 (0)20 7183 7061.