Job Opening for Director, Clinical Data Management in Technical Resources International, Inc. (6500 Rock Spring Dr # 650, Bethesda, MD 20817)

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Job Category : Management
Company Name: Technical Resources International, Inc.
Position Name: Director, Clinical Data Management
Location : 6500 Rock Spring Dr # 650, Bethesda, MD 20817
Job Description : Responsibilities: Oversee statistical programming, analysis, and reporting activities for Phase I-IV clinical studies, integrated databases and analyses, safety reviews and ad-hoc analyses Supervise Statistical and Data Programming staff, with all incumbent supervisory responsibilities Establish staff competency requirements and training programs Mentor staff and aid in their development and achievement of competency standards Standardize, improve, and develop SOPs for data analysis and reporting processes. Prepare statistical analysis plans for single projects, integrated summaries of safety, and integrated summaries of efficacy Approve case report form design, data management plans, and edit specifications Prepare statistical sections of protocols, including sample size calculations; develop randomization specifications and verify randomization codes for basic and complex clinical trials; prepare and annotate shell data displays, perform validation and quality control of complex data displays, write statistical reports and statistical section of clinical study reports Support project teams on achieving client satisfaction through delivery of quality data, on-time and on-budget Ensure revenue and operating margin performance of the data management group to agreed targets Review literature and research technologies/procedures for improving statistics and programming practices Support business development and marketing activities at client presentations and professional seminars Participate in proposal development and defense processes Establish and maintain strategic client relationships Requirements: Experience overseeing projects that include Safety, Regulatory, and Site Operation components, in addition to Data Management and Biostatistics, highly desired PhD, or relative work experience in related discipline, preferred Broad knowledge and superior understanding of advanced statistical concepts and techniques Advanced SAS programming knowledge and proficiency with other statistical packages and sample size calculation software Familiarity with EDC systems Expert knowledge of clinical data standards and data flows as well as industry standards for submission of data Experience overseeing projects that include safety, regulatory, and site operation components, in addition to data management and biostatistics Client management experience Excellent oral and written English and good presentation skills Knowledge of the drug development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical and medical device business. Proven ability to plan and manage capital and operating budgets, as well as plan and advocate staffing resources Recommended Skills Biostatistics Biotechnology Business Development Calculations Case Report Forms Clinical Study Reports Job Snapshot Employee Type Full-Time Location Bethesda, MD Job Type Information Technology Experience Not Specified Date Posted 02/09/2022 Job ID 440/159/828
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