Position type: Permanent, Full time
Location: Oxford (remote working with occasional days in the office)
Salary: Up to £30k plus Benefits including Bonus
Our Client, a specialist CRO is seeking a Senior Clinical Data Analyst to work closely with their clients to ensure the solution and services provided meet their requirements across multiple studies.
Role and Responsibilities
• 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.
• 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 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 an ability to work to tight deadlines
• 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