Senior Clinical Data Analyst

Title: Senior Clinical Data Analyst
Position type: Permanent, Full time
Location: P1vital Products Ltd, Manor House, Howbery Park, Wallingford, Oxfordshire, OX10 8BA
Reports to: Clinical Data Manager

Role and responsibilities:

  • Work closely with our clients to ensure the solution and services provided meet their requirements
  • Develop study user requirement specifications, requirement traceability matrices and test cases for our digital solutions based on clinical study protocols
  • Work closely with the IT team to ensure they have a good understanding of any changes that are required to the digital solutions to support the study requirements
  • Develop clinical study training materials including training guides, system manuals and e-learning presentations utilising the Learning Management System.  For cognitive task related training, work closely with the Science team
  • Manage data management and statistical analysis services ensuring high quality and completeness of data through collection, processing, querying, and report generation in accordance with data management plans, data transfer specifications and statistical analysis plans.  Ensure compliance to CDISC standard throughout
  • Manage study helpdesk support on an ongoing basis ensuring a quality and timely response to support requests, in line with internal performance metrics
  • Work closely with the Computer Systems Validation Manager and QA Coordinator to ensure all documentation and processes are in accordance with our Quality Management System
  • Pursue continuous professional development through company paid internal / external training, certifications and/or continuing education
  • Assume line management responsibilities within the Data Management team, as required, providing mentorship to direct reports

Skills and experience:

  • Graduate with a Computational Science, IT or equivalent degree (IIi or above) and/or a higher degree
  • Experience (minimum 2 years) of clinical trials, preferably in clinical data management
  • Experience of GCP, providing digital solution services for clinical trials
  • Knowledge of information management systems
  • Proven experience in MatLab and/or statistical programming
  • Strong organisational, planning and time management skills
  • Good prioritisation skills and be flexible enough to adapt plans
  • An ability to work to tight deadlines and within constraints
  • A good team-playing mentality
  • Excellent logical, analytical and problem solving skills
  • A concern for quality, attention to detail and accuracy
  • Confidence in decision-making
  • Good communications skills – written and verbal
  • Background in mentoring junior support staff
  • Advanced IT skills with MS office suite including Excel

To find out more or apply, please email your CV to dmays@p1vital.com