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

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons or because the individual is pregnant or attempting to become pregnant. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply depending on which campus you will work.  Your recruiter will advise accordingly.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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