About this role
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Project Management
• Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
Statistical Programming for Assigned Projects
• Deliver best value and high quality service. • Check own work in an ongoing way to ensure first-time quality. • Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. • Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.
Training
• Maintain and expand local and international regulatory knowledge within the clinical industry. • Develop knowledge of SAS and processes/procedures within other Parexel functional areas. • Provide relevant training and mentorship to staff and project teams as appropriate.
General
• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulator compliance. • Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. • Proactively participate in process/quality improvement initiatives. • Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
Skills:
• Excellent analytical skills. • Proficiency in SAS. • Knowledge and understanding of the programming and reporting process. • Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. • Ability to learn new systems and function in an evolving technical environment. • Ability to manage competing priorities and flexibility to change. • Attention to detail. • Ability to successfully work as part of a global team. • Work effectively in a quality-focused environment. • Effective time management in order to meet daily metrics or team objectives. • Show commitment to and perform consistently high quality work. • Business/operational skills that include customer focus, commitment to quality management, and problem solving.
Knowledge and Experience:
• Competent in written and oral English. • Good communication skills.
Education:
• Educated to degree level in a relevant discipline and/or equivalent work experience.