Overview
At the heart of QIAGEN's business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. Our most valuable asset are our employees - more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us. There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started. If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be. Join us. At QIAGEN, you make a difference every day.
Position Description Summary: The SCDM serves as the functional lead of clinical data management for regional team interacting with Clinical Study Leads (CSL) on assigned business targets. SCDM manages the whole data processes, governs clinical data workflows globally, and accounts for on-time deliveries of data milestones adhering to goals of projects. SCDM assures data processes and documents being performed in conformity with SOPs, and in compliance of data integrity and relevant local regulations & GCP guidelines. SCDM could serve as line manager of Regional Clinical Data Managers (CDM) and Clinical Data Specialist (CDS) for regional team upon organization needs.
Primary responsibilities of the position Leads setting up and constant improving / maintaining global clinical data management procedures (SOPs, instructions / templates, management tools) in line with regulations / regulatory guidelines. Oversees the compliance of data workflows in regards to SOPs for all regional studies.Leads the development of data management, data analysis and reporting systems throughout clinical studies satisfying project timeline and study requirements which upfronted by CSL. Establishes data capture / transfer workflows (e.g. EDC), data processing and statistics tools (e.g. SAS programming), and generates data reports.Oversees document integrity for data files, and conducts quality assurance evaluations / measures on data and statistic processes ensuring integrity and traceability.Selects and qualifies outsource partners / service vendors / contractors for solutions of data management and statistics needs. Oversees the performance and quality according to SOPs and project requirements.Works closely with CSL, finance and procurement to manage budgets, contracts and invoicing for outsourced services.Oversees the upgrades and changes of regional clinical regulations / guidelines related to data management standards. Responsible for training global clinical team on the new requirements.Where assigned, acts as particular study data manager on responsibilities, or coaches and instructs CDMs/CDSs.Position Requirements Essential skills & Experience:
Master degree in bio- / medical- statistics, or other clinical data related areas.Minimum 4 years working experiences of clinical data management with IVD company; other devices or pharmaceutical clinical operation experience will be considered.Certification of GCP, and essential understanding of GCP requirements on clinical data and statistics.Hands-on knowledge of Regulatory requirements of assigned working regions (e.g. FDA, CE, ICH GCP, ISO 14155/20916, NMPA, etc).Skills capable of interpreting regulations and guidelines on IVD / MD for actionable insights of sample size, database design, data collections, statistic criteria, statistic methods and study evaluations.Hands on experiences of Electronic Data Capture (EDC) and Clinical Data Management System (CDMS). Essential understanding of clinical data standards.Hands on skills proficient of programing with Excel Advance, SAS and SPSS.Skills and experiences competent of driving multiple stakeholders and joint actions in project organizations. Resilient to timeline pressure and urgency. Proactive and effective communications, averting procrastination and efficiency driven.Proficient English oral and written communication, especially technical reading and writing skills; local language proficiency required if assigned to specific regions.Desirable Education and experience background:
Advanced Degree in bio- / medical- statistics, or other clinical data related areas.Knowledge in IVD product especially molecular diagnostics preferred, capable of understanding of IVD product design control process, CLSI guidelines, ISO 13485, etc.Authoring or facilitating clinical study designs e.g. Protocols, CRFs, database and data workflow.
#J-18808-Ljbffr