Clinical Data Analyst

Position type: Permanent, Full time
Location: Wallingford, UK (Due to COVID-19 remote working will be required initially)

Role and responsibilities

We have an excellent opportunity for an individual with an interest in clinical data management to be part of a growing multi-functional team to manage and maintain clinical study and healthcare data. P1vital Products Limited (PPL) is a leader in developing software and products for the pharmaceutical and healthcare sectors.

Reporting to the Clinical Data Manager, the Clinical Data Analyst will be responsible for managing the clinical data for our pharmaceutical and healthcare clients; specifically:

– Preparation of data management documentation (e.g. Data Management Plan, Data Transfer Agreements etc.)
– Performing data validation checks, raising data queries/data issues, and reconciliation of data from external sources (e.g. lab data etc.) as per DMVP
– Preparation of study datasets for statistical analysis and execution of data transfers
– Handling and maintenance of data management trackers and data reports
– Interacting with external data providers, and communicating across multiple study teams both internally and externally
– Experience in using EDC(eCRF/ePRO/eCOA) systems and designing of (e)CRFs for clinical studies
– Experience in user acceptance testing and validation of EDC systems
– Experience in designing and coding databases (ideally to CDISC standard)
– Providing support and guidance to study sites for clinical studies
– Responsible for the training, certification and maintenance (e.g. registration of site user accounts) of study EDC systems throughout the clinical study
– Archiving of study documentation and EDC data

Skills and experience

– At least 1-2 years proven experience of Clinical Data Management within a Biotech/CRO/Pharma setting
– Graduate with Life Science, Computer Science or equivalent degree (IIi or above) and/or a higher degree
– Excellent organisational, planning and time management skills
– Excellent communication skills (both written and oral)
– Ability to work independently in a fast-paced environment
– Ability to work effectively with others
– Excellent logical and analytical thinking
– Creative problem solving ability
– High level of attention to detail and accuracy
– Advanced IT skills with MS office suite including Excel
– Working knowledge of CDISC
– Working knowledge of coding medical terms (ideally MedDRA)

If you are interested in applying for this role please email your CV with a cover letter to recruitment@p1vital.com.