Sr. Research Data Manager

The Transplant Oncology and Infectious Diseases Clinical Research Center (TOID CRC) is looking for an experiencedSr. Research Data Managerto implement and oversee 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.

This position will be responsible for 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 Sr. Data Manager will also act as coach, mentor and/or subject matter expert within TOIC CRC, aiding the Project Manager in process improvements, issue escalation and training development and delivery. The position will support the TOID CRC in achieving objectives and strategic goals.

Specific Duties and Responsibilities:

Participate as a collaborative member of the senior research team, serving as the content specialist on data management aspects for clinical trials including start-up, maintenance, and close-out activities. 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 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 clinical database management, data verification, data cleaning, and quality assurance of multiple projects. Responsible for of all mid-study changes to database. Creates and maintains data management documents per SOP (e.g. Data Management Plan, Data Validation Plan, Data Entry Guidelines, Data Transfer Agreements, etc.). 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 and CRC Monitors. Prepare reports and assist with data presentations. Responsible for overseeing database lock and transfer process. Validates clinical trial database on an ongoing basis for accuracy, completeness and consistency. Coach, mentor and/or train peers, contribute to peer selection, performance evaluation, peer orientation and project communications. Conducts staff and clinical site training specific to database and data management as required.

Minimum Qualifications (Mandatory):

• Bachelor's degree in health science, public health, epidemiology, or related discipline.
• 5 years related experience.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Master’s degree in health science, public health, epidemiology, or closely related field. Experience data managing Clinical Trials. Experience working with REDCap.

Must be able to demonstrate skills in core data management activates (e.g. data management plans, edit specifications, utilizing data dictionaries, electronic data transfers, data quality reviews and reporting. Exceptional written and verbal communication skills, ability to work as part of a team, proficiency in Microsoft Office Suite, meticulous record keeping.

Reports To:

• Director of Operations; Darin Ostrander, PhD
• Program Manager; Diane Brown, MSN

JHU Equivalency Formula:18 graduate degree credits may substitute for one year of experience. 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: Sr. Research Data Manager
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $52,495 - $72,210 annually (commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30-5pm
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 atjhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

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

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

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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