Data Management Lead II (South Africa)
Parexel International Corporation
South Africa - Any Region - Home Based
The Data Management Lead ll provides leadership and expertise in all aspects of Data Management. Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management’s single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, financial management and quality. The Data Management Lead ll works with minimal guidance from their Line Manager and/or Subject Matter Experts. DML's may act as a mentor for ADML's or other DML peers. May act as Project Leader for projects involving only Global Data Operations services.QualificationsStrong data management or related experience in clinical research industry essential.
• Proven record of leading project and program teams
• Good understanding and application of Parexel project tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
• Good understanding of Clinical Study Team roles outside of Data Management
• Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOP's and study specific procedures
• Awareness of SDTM/CDISC/CDASH standards
• Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products
Bachelor’s degree and/or other qualifications in a science or clinical related industry