Description
General Summary of Position
Manager Data Management
Washington, DC
MedStar Health Research Institute
MedStar Health Research Institute has an opening for a Manager Data Management to join our team!
Job Duties:
Plan, organize and manage all aspects of the assigned clinical trial. Lead the efforts of all key functional departments to perform all project-related activities according to project milestones by overseeing the Standard Operating Procedures for Data Management (DM) within MCRN's Data Center and facilitating the DM plans, edit checks and related requirements for study-level data lock. Liaise with scientific leads on the development and implementation of data repositories for current and future work leveraging existing and new data requirements. Collaborate with the Center for Databases and Programming Technologies in Report Form design, preparation of building, deployment, queries and final report generation. Manage the following task completions: logging incoming case report forms, data clarification forms, edit checks design and execution, serious adverse events notification, queries and study related report requests, resolution of data entry discrepancies, and entry data clarification responses and investigating data anomalies. Prepare materials for both clinical events committee and data safety monitoring boards as applicable. Implement and apply federal, state, local, and other regulations and guidelines pertaining to research in the conduct of research work to ensure the highest quality research activities from site selection through study closure.
Position requires 10% domestic travel to study sites and attend conferences.
Requirements:
Position requires a Master's degree in Public Health, Life Sciences or related healthcare field of study. Will accept foreign educational equivalent.
Position requires 32 months of experience as a Data Manager, Research Fellow or related occupation. Position requires 32 months of experience with Computer software applications, including Excel, Access, SharePoint, Visio and coding. Position requires one (1) year of experience in the following: Phase I-IV or pivotal clinical trials; FDA, ICH, GC and other regulatory functions, including command of all the CFR and ICH guidelines; and Relational databases including oracle, redcap, sequel or OMAP.
Location:
MedStar Washington Hospital Center, 110 Irving Street NW, Washington, DC 20010
Salary: $111,238.00 to $175,968.00 per year
Why join MedStar Medical Group?
We are a progressive, forward-thinking organization that enables you to define your own future—by region, specialty, or professional interest. We are also among the nation's 15 largest medical groups, with the resources of highly respected MedStar Health behind us. We are collaborative, too. Your input and opinions concerning quality of patient care, your practice and this organization truly matter. You'll also find balance here. We work hard, but we also value our personal lives and pursuits beyond the workplace. If you want an exciting career that is always challenging, always rewarding, apply now.
This position has a hiring range of $111,238 - $175,968
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