Senior Data Manager, Lombardi Comprehensive Cancer Center -- Georgetown University Medical Center

Georgetown University
life insurance, tuition assistance
United States, D.C., Washington
September 13, 2023
Senior Data Manager, Lombardi Comprehensive Cancer Center -- Georgetown University Medical Center Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world. Requirements The Senior Data Manager is responsible for the supervision and support of data manager I and IIs within the Lombardi Comprehensive Cancer Center (LCCC) Clinical Research Management Office (CRMO), which are responsible for the data management of phase I, II, and III oncology clinical trials conducted at LCCC. Duties include but are not limited to: Provide leadership and support for all aspects of clinical research data management for clinical trials conducted in the LCCC Clinical Research Management Office (CRMO). Provide supervision and support and serve as a resource to the data management team staff members. Provide training to data managers on the review, analysis, and extraction of data from source documents and medical records; completion of case report forms; meeting data entry requirements and timelines; institutional and CRMO policies; the use of electronic data capture systems; query resolution; and uploading radiological images to imaging platforms. Ensure competency of data managers utilizing a standardized competency tool. Responsible for the oversight of trials of varying complexity and disease indication. Distribute staff assignments to ensure a balanced workload across the team. Work collaboratively and communicate appropriately with trial stakeholders, internal study teams, external departments, and study sponsors. Proficient in data management processes for industry, national, and investigator-initiated studies. Ensure adherence to contractual timelines and site Standard Operating Procedures (SOPs). Ensure query resolution within site- and sponsor-specific time requirements. Ensure accuracy of data entered in the Clinical Trials Management System (CTMS). Interface with sponsor representatives regarding study visits and other issues. Ensure team members address outstanding monitoring report findings. Lead audit preparation for internal and external audits, including supporting data deficiency corrections and development and implementation of corrective actions plans post-audit. Participate in the feasibility evaluation of new clinical trials. When applicable, attend protocol-related training and complete all required study training in the required timeframe. Assure ongoing compliance with all departmental, institutional, and federal requirements and regulations. Develop and implement internal controls to assure accuracy, completeness, timeliness, and confidentiality of reported research data. Maintain confidentiality standards for all potential and enrolled study participants; comply with federal Health Insurance Portability and Accountability Act (HIPAA) regulations. Provide regular reports on data entry timelines, database locks, unique study requirements, and query management to appropriate study teams and Disease Groups. Other duties as assigned. Performs all duties in accordance with all applicable laws and regulations. Adheres to Georgetown University Medical Center's philosophies, policies, and SOPs. Works in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice. Work Interactions Clinical Research Manager Disease Group members: Principal Investigators, Physicians, Clinicians Clinical Research Management Office (CRMO) members: CRMO Management team, Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, Laboratory Technicians External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff Clinical trial sponsors, auditors, and study monitors Qualifications Bachelor's degree required. Master's degree strongly preferred. Three (3) to five (5) years of related experience required. Strong candidates exhibit: Ability to work independently and function within a team. Strong attention to detail. Reliable and able to prioritize competing responsibilities. Current Georgetown Employees: If you currently work at Georgetown University, please exit this website and login to GMS () using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown. Submission Guidelines: Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions. Need Assistance: If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or . Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works . EEO Statement: Georgetown University is an fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law. Benefits: Georgetown University offers a wide variety of comprehensive and competitive benefits. Benefits packages include comprehensive health, dental and vision plans, disability and life insurance coverage, retirement savings programs, tuition assistance, voluntary insurance options (including group legal, accident, and critical illness), and much more. Whatever your need, the Office of Faculty and Staff Benefits will be standing by to support you. 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