Senior Data Manager - Georgetown University Medical Center
- Employer
- Georgetown University
- Location
- Washington D.C
- Closing date
- Jun 16, 2019
View more
- Industry
- Education
- Function
- Medical Doctor and Physician, Management
- Hours
- Full Time
- Career Level
- Experienced (Non-Manager)
Job Details
Requirements
The Senior Data Manager oversees a group of data managers LeveI I and Level II, as well as trains, mentors and instructs data teams regarding data management and prioritizing deadlines. S/he is responsible for the management of the data for complex clinical trials, including data entry for assigned trials in a timely manner. Reporting to the Supervisor and assuring data quality, accuracy and completeness, the Senior Data Manager has additional duties that include but are not limited to:
Supervision and Mentoring
- Oversees prioritization of studies of varying complexity (such as high accrual, Phase I, data locks, and audits) for the data team.
- Assists Data managers with prioritization of data entry for assigned trials.
- Assists data managers with the preparation for internal and external audits, performing the annual evaluations.
Data Entry
- Handles data entry and query resolution on assigned trials.
- Prepares data for monitoring and auditing visits.
- Assists researchers in retrieving information from the databases and other data sources, as well as provides research and management reports as required.
- Coordinates and organizes the data entry, data locks, monitoring, and audit deadlines in their disease group team for complex clinical trial portfolios.
- Ensures that clinical trial data is high integrity, high quality, and entered in a timely manner to meet protocol requirements.
- Manages query resolution in a timely manner and appropriate communication with study team and sponsor.
Organizational Duties
- Communicates study status, timeline updates, and data deadlines to supervisor and other Senior Data Managers.
- Works with the supervisor in establishing and maintaining departmental SOP development and implementation.
- Collaborates with the QA manager and Senior DMs to identify areas requiring further education and quality improvement.
- Participates in CRMO Manager's meeting.
Qualifications
- Bachelor Degree; Master's Degree preferred
- Minimum of two years of data management experience and knowledge of data entry systems
- Knowledge or regulatory requirements, FDA regulations, Good Clinical Practices (GCPs), international guidelines, and other guidelines for clinical research
- Excellent communication skills and the ability to interact with investigators on a wide variety of research protocols
- Ability to work in a clinical research setting both independently and within a team with strong communications skills, both verbal and written
- Excellent analytical, organizational, and time management skills with the ability to multi-task and pay close attention to detail
- Experience with clinical research database systems as well as experience or the ability to acquire expertise with Oracle platforms, Rave and Oncore preferred
Company
Founded in 1789, the same year the U.S. Constitution took effect, Georgetown University is the nation's oldest Catholic and Jesuit university. Georgetown today is a major student-centered, international, research university offering respected undergraduate, graduate and professional programs on its three campuses in Washington, DC.
Georgetown University is a leading employer in the Washington, DC metropolitan area and offers prospective employees an opportunity to work with the best and the brightest in a caring, diverse and intellectually stimulating campus environment. The University is world renowned for its academic and research programs which provide our faculty and staff with unprecedented career challenges and growth opportunities. Enjoy working with our students and professional colleagues who are proud of their accomplishments and strive to be leaders in their respective fields.
Georgetown University is an Affirmative Action/Equal Opportunity Employer that is committed to diversity in the workplace.
GEORGETOWN UNIVERSITY OFFERS ATTRACTIVE BENEFITS, INCLUDING A TUITION ASSISTANCE PLAN.
- Website
- http://www.georgetown.edu/
- Telephone
- 2026872008
- Location
-
37th & O Streets, NW
Suite 1200A
Washington
DC
20057
US
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