Sr. Clinical Research Data Manager

Davita Inc.; Baltimore (MD); Hybrid; USD 55,000 - 98,000; Full time

Job summary

A leading healthcare provider is seeking a Sr. Clinical Research Data Manager to oversee data collection and integrity for neonatal units across several hospitals. The role involves managing complex databases, supervising staff, and ensuring compliance with HIPAA guidelines while supporting quality improvement initiatives in neonatal care. Ideal candidates will have a blend of clinical knowledge, organizational skills, and experience with electronic medical records.

Qualifications

• 5 years related experience in clinical data management.
• Knowledge of neonatology and obstetrics required.
• Medical training as RN, NNP or MD preferred.

Responsibilities

• Manage data collection and submission for neonatal units.
• Supervise data management staff and ensure data integrity.
• Perform audits and prepare reports as needed.

Skills

Detail-oriented

Organizational skills

Communication skills

Analytical skills

Education

Bachelor's Degree in related discipline

Tools

EPIC EMR

e-NICQ software

Job description

We are seeking a Sr. Clinical Research Data Manager to be responsible for the collection, submission, and integrity of maternal and infant data for all admissions to the Johns Hopkins Hospital (JHH) NICU, Johns Hopkins Bayview Medical Center (JHBMC) NICU and the Johns Hopkins Howard County Medical Center (JHHCMC) NICU using the Vermont Oxford Network (VON) Database. The total number of admissions for the combined units is 1,300-1,600 infants annually.

Vermont Oxford Network is a nonprofit voluntary collaboration of 1,300 member centers where healthcare professionals work together as an interdisciplinary community to improve the quality, safety, and value of care for newborns and their families through a coordinated program of data-driven quality improvement, education, and research.

The Sr. Clinical Research Data Manager receives and responds to all VON correspondence regarding data status, submission, and errors. Supervise other data management staff, often at affiliated hospitals or referral centers to ensure timely, accurate data. Responsible for confirming data integrity, managing the database and finalization of data.

The VON database is the main clinical research database for our NICUs. Participation in VON is mandatory for all Level III and IV NICUs in the state of Maryland, per the Maryland Institute for Emergency Medical Services Systems (MIEMSS) and COMAR regulations. This database is also utilized for Leapfrog Hospital Safety Grade reporting, the Accreditation Council for Graduate Medical Education (ACGME) certification for the Neonatal-Perinatal fellowship training program, Department of Pediatrics resource planning, NICU clinical quality improvement (QI) initiatives, and for pilot data to support research grant submissions.

This position reports to the Neonatology Regional Medical Director, dotted line to Division Director and Division Administrator.

Specific Duties & Responsibilities

• Screen Daily NICU Admission log to identify neonates at JHH, JHBMC and JHHCMC NICUs that meet database eligibility.
• Utilize STRICT data definitions from VON to collect patient data from EPIC for all NICU admissions.
• Perform extensive data collections using VON's e-NICQ software. Enter the raw data into the VON Databases using e-NICQ software.
• Collect and enter data in a timely manner and meet annual deadlines for data submission.
• Manage large, complex, longitudinal databases for research and QI projects.
• Create strategies for capturing, cleaning, and quality control checks.
• Maintain three separate hospital-based VON databases: JHH, JHBMC, and JHHCMC NICUs.
• Take appropriate measures to ensure that patient-specific information is protected and secure from unauthorized access when collecting, recording, submitting, or storing data, strictly following HIPAA guidelines.
• Audit each center's VON submissions. Closely track and report the patients transported within or outside the system to ensure site-specific accuracy of data entry.
• Submit and finalize all data to VON.
• Provide VON reports to site Medical Directors and Director of Q&S/Neonatology Regional Medical Director. Reports will be summarized and shared with Neonatology Faculty, NICU Nursing Administration, and others to facilitate QI efforts and research.
• Maintain and supervise data collection at affiliated and referral centers (data is collected for all infants from birth until discharge home including data from other NICUs/hospitals/nursing units that infants are transferred to or from during hospitalization).
• Prepare annual reports for Neonatology Leadership as requested.
• Provide timely data to support quality improvement initiatives as requested (e.g., increasing the number of breastfeeding mothers).
• Provide data for NICU monthly meetings as requested, such as NICU Process Improvement committee and Comprehensive Unit Based Safety Program (CUSP).
• Provide data to support the Annual US News and World Reports (USNWR) survey questionnaire.
• Provide data to neonatal faculty regarding the number of admissions and specific diagnoses to support internal and external grant applications.
• Provide pilot data for faculty grant submissions.
• Export data and compile reports as needed

Special Knowledge, Skills, and Abilities

• Detailed clinical knowledge of neonatology and obstetrics is required. It is critical to report the data only as it relates to the specific data definitions from VON. The ideal candidate must be able to recognize errors and inaccuracies in the Electronic Medical Record (EMR), and interpret the data within the scope of the whole patient encounter from admission to discharge.
• Ability to read and understand technical information such as serial head sonograms is critical.
• Must be proficient using electronic EMR.
• Ideal candidate must exhibit excellent organizational skills.
• Must be detail-oriented and display proven ability to work independently almost exclusively.
• Proven strong written and oral communication skills and interpersonal skills are required.
• Highly self-motivated and directed.
• Exercise sound judgement on a regular and ongoing basis.
• Maintain patient confidentiality under the current HIPAA guidelines.
• The qualified candidate must demonstrate the ability to communicate on a professional level, act appropriately and effectively with all levels of clinical, research and administrative faculty, staff and students.
• Able to represent JHMI professionally when collaborating with all levels of leadership at other medical institutions to complete data capture.
• Must be flexible and adaptable in regard to learning and understanding new technologies and possess proven analytical and problem-solving abilities.
• Must be highly logical and technically proficient.

**Indirect supervision via developing and maintaining relationships to oversee the quality of data received from referring hospitals and those to whom we transfer for convalescent care (includes 15-20 hospitals)

Technical Qualifications or Specialized Certifications

• EPIC proficiency required, especially inpatient encounters.
• Undergo training in the use of the VON e-NICQ software, and become proficient within the first 6 months is required.
• Licensed in MD to have access to EPIC, to access patient information.

NOTE: Remote work is allowable as long as stable internet access to the servers located at JHMI site is readily available.

Minimum Qualifications

• Bachelor's Degree in related discipline.
• Five years related experience.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond HS diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Medical training as RN, NNP or MD.
• At least 3 years of neonatology experience and/or experience working in a clinical position in a Level III or Level IV NICU strongly preferred.
• Master's Degree
• EPIC EMR strongly experience preferred

Classified Title: Sr. Research Data Manager
Job Posting Title (Working Title):Sr. Clinical Research Data Manager
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually ($85,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday - Friday, 7.5 hrs/day; 37.5 hrs/week
FLSA Status:Exempt
Location: Remote
Department name: SOM Ped NICU
Personnel area: School of Medicine

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University's salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: 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 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.

Applicants Completing Studies
Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Background Checks
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEOis the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
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 Talent Acquisition Office at [e-mail]. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine.The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry.This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. 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 upon campus. 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.