Job Description

Job Description - Senior Clinical Research Data Manager (240003IB) Job Description Senior Clinical Research Data Manager - (240003IB) Description The Sr Clinical Data Manager will help oversee the clinical database and clinical data management aspects of the Biostatistical and Study Methodology Division and provide support for the implementation of project specific database design, creation and testing. Train staff on implementation of clinical data management SOPs and policies. Choose and implement appropriate methods to address clinical research questions by preparing tables, graphs, and results and written interpretation. Work closely with all Coordinating Center staff and study team leadership to accomplish these goals. Qualifications Minimum Education Bachelor's Degree in applicable fields such as Epidemiology, Biostatistics, Information Systems or a related field. (Required) Master's Degree in applicable fields such as Epidemiology, Biostatistics, Information Systems or a related field (Preferred) Minimum Work Experience 3 years of demonstrated data management in FDA regulated clinical studies in human subjects. (Required) 5 years of demonstrated data management in FDA regulated clinical studies in human subjects. (Preferred) Required Skills/Knowledge Knowledge of REDCap, OpenClinica, SAS or other database systems Demonstrated excellent written, verbal, interpersonal and communication skills Good multi-tasking and organizational skills. Understanding of statistical reporting and basic analysis functions Functional Accountabilities Database Management Work directly with the client on the creation of clinical study databases. Prepare Clinical Data Management Plans for complex studies. Oversee the development and implementation of data validation checks and query programs. Prepare, update and review clinical data management documentation. Oversee project specific clinical database design, creation and testing. Oversee the testing of clinical data management system edit/validation checks and discrepancy management activities. Provide support and act as the Senior Clinical Data management point person to the Sponsor, CROs, vendors, clinical sites, and scorers. Develop presentations and present at Investigator meetings. Train, track, and manage users on the CDMS. Manage delivery of projects through full clinical data management process life-cycle. Create, track, and manage clinical data management timelines, proposals, and budgets. Standard Operating Procedures Write SOPs, database templates and forms. Train staff to implement clinical data management SOPs and policies. Creation, completion, organization, and tracking of all data management documentation. Develop, edit, and review Standard Operating Procedures and Work Instructions as needed. Follow and ensure compliance with current Good Clinical Practices (cGCPs). Clinical Data Analysis and Reporting Expertise in biostatistics and epidemiology to choose appropriate methods to address research questions. Implement chosen methods to ensure underlying assumptions are met. Prepare tables, graphs, results, written interpretation and descriptions for incorporation into publications. Anticipate and respond to customer needs; follow up until needs are met. Teamwork/Communication Demonstrate collaborative and respectful behavior. Partner with all team members to achieve goals. Be receptive to others’ ideas and opinions. Performance Improvement/Problem-solving Contribute to a positive work environment. Demonstrate flexibility and willingness to change. Identify opportunities to improve clinical and administrative processes. Make appropriate decisions, using sound judgment. Use resources efficiently. Search for less costly ways of doing things. Safety Speak up when team members exhibit unsafe behavior or performance. Continuously validate and verify information needed for decision making or documentation. Stop in the face of uncertainty and take time to resolve the situation. Demonstrate accurate, clear and timely verbal and written communication. Actively promote safety for patients, families, visitors and co-workers. Attend carefully to important details - practicing Stop, Think, Act and Review to self-check behavior and performance. Primary Location District of Columbia-Washington Work Locations Remote Work Location 111 Michigan Avenue NW Washington 20010 Job Non-Clinical Professional Organization Scientific Director Position Status: R (Regular) - FT - Full-Time Shift: Day Work Schedule: M-F, 40hrs/week Job Posting Full-Time Salary Range 72550.4 - 120910.4 Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “Know Your Rights” poster is available here: and the pay transparency policy is available here: Know Your Rights Pay Transparency Nondiscrimination Poster. Please note that it is the policy of Children's National Hospital to ensure a “drug-free” work environment. #J-18808-Ljbffr Children's National Medical Center

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