The Transplant Oncology and Infectious Diseases Clinical Research Center (TOID CRC) is looking for a Research Data Manager to assist with multiple single center and multi-centered national studies as assigned. Our research focuses on solid organ transplantation and in particular, novel transplantation practices such as organ donation from donors with HIV and hepatitis C. We are also studying COVID -19 in the transplant recipient population. Under the direction of the Program Manager and Sr. Data Manager, this position will be responsible for participating in the planning and execution of all data management activities for assigned projects, ensuring focus on data integrity, validity, and reliability in accordance with standard processes, sponsor guidelines, industry best practices and regulatory standards. The position will support the TOID CRC in achieving objectives and strategic goals. This role reports to the Director of Operations; Darin Ostrander, Phd and Program Manager; Diane Brown, MSN.
Specific Duties & Responsibilities:
Works with cross-functional teams in designing, building, testing, and implementing studies in Electronic Data Capture systems, i.e REDCap.
In collaboration with Project Manager (PM) and Sr. Data Manager develops study specific electronic or paper Case Report Forms (CRFs), ensuring consistency with study protocol, clinical requirements, and accurate and efficient data collection.
Responsible for assisting with clinical database management, data verification, data cleaning, and quality assurance of multiple projects.
Responsible for appropriately executing of all mid-study changes to database per internal policies.
Assists in maintaining data management documents per SOP (e.g. Data Management Plan, Data Validation Plan, Data Entry Guidelines, Data Transfer Agreements, etc.).
Under the direction of the PM and/or Sr. Data Manager creates and cleans edit checks to ensure data are in accordance with Good Clinical Practices (GCP) and study protocols.
Designs and generates data queries and reports to expedite resolution of queries and to improve quality of data being collected, working in close collaboration with Project Manager, Sr. Data Manager, and CRC Monitors.
Prepare reports and assist with data presentations.
Responsible for assisting with database lock and transfer process.
Validates clinical trial database on an ongoing basis for accuracy, completeness and consistency.
Minimum Qualifications (Mandatory):
Bachelor's Degree in Health Science, Public Health, Epidemiology, or closely related field and a minimum of three years of data management experience. Master's degree in Health Science, Public Health, Epidemiology, or closely related field, may substitute for experience, to the extent permitted by the JHU equivalency formula.
Experience in data managing Clinical Trials and Experience working with REDCap is preferred.
Special Knowledge, Skills & Abilities:
Exceptional written and verbal communication skills, ability to work as part of a team, proficiency in Microsoft Office Suite, meticulous record keeping
Additional Requirements for the Position:
Required work schedule 5 days per week.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Classified Title: Research Data Manager Role/Level/Range: ACRP/04/MC Starting Salary Range: $45,650 - $62,850 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 8:30am - 5pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM DOM Infectious Disease Personnel area: School of Medicine
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