Research Data Manager

Johns Hopkins University; Baltimore (MD); Remote; USD 48,000 - 84,000; Full time

Job summary

The Neurology Department at a leading university seeks a Research Data Manager for data management in clinical trials. This role requires independent action, sharp negotiation skills, and proficiency in programming languages like R, SAS, or Python. The successful candidate will engage with multi-center studies, ensuring data integrity and compliance with regulatory standards.

Qualifications

• 3 years related experience required.
• Experience in data management for clinical trials.
• Ability to present to investigative teams and subject-matter experts.

Responsibilities

• Program reports for tracking study performance like enrollment projections.
• Independently build electronic case report forms in RedCap.
• Assist in developing electronic data capture platforms for clinical trials.

Skills

Negotiation

Facilitation

Consensus-building

Diplomacy

Helpline orientation

Education

Bachelor's Degree in related discipline

Tools

SQL

R

SAS

Python

RedCap

Job description

The Neurology Department is seeking a Research Data Manager to perform data management for complex, multi-center, or longitudinal clinical trials for BIOS Clinical Trials Coordinating Center (CTCC). This role acts as the primary contact for multi-center study staff regarding data issues. As a Research Data Manager, you will support the innovative work of BIOS CTCC as a member of the BIOS Data Core team. BIOS CTCC manages multi-center, federally funded clinical trials worth over $30 million, as well as multiple site-specific pharmaceutical-sponsored trials. The successful candidate will be expected to operate independently, with guidance provided by BIOS leadership. 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. This position reports to the BIOS Faculty and leadership.

This position can be remote and requires a high degree of independent action and adherence to strict timelines. Building and maintaining strong, trusting relationships is critical. The successful candidate must possess excellent negotiation, facilitation, consensus-building, and diplomacy skills and exhibit a strong helpline orientation. The successful candidate will be expected to stay current with constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate, and remodel. This individual will serve as a knowledgeable liaison between the BIOS leadership and the research communities.

Specific Duties & Responsibilities

• Program reports for tracking study performance such as study enrollment projections, site-based screening and enrollment, query resolution, and deviation reports.
• Provide user management and support for trial database and web-based servers.
• Independently build electronic case report forms in RedCap.
• Assist in developing and maintaining electronic data capture platforms for multi-site, complex, longitudinal clinical trials leveraging advanced electronic data capture systems.
• Serve as a resource for technical feasibility of database changes and functionality
• Generate and distribute data queries and study progress reports to trial management teams
• Assist with site team training on database functionality and use.
• Maintain compliance with enrollment reporting requirements for NIH-sponsored studies
• Assist with preparing data use agreements and fulfilling data sharing requests.
• Other data management activities as assigned with a willingness to learn new skills and processes.

Minimum Qualifications

• Bachelor's Degree in related discipline.
• Three years related experience.
• Proficient in at least one of the following programming languages: R, SAS, Python, with a working knowledge of SQL.

• Experience in data management for clinical trials.
• Experience presenting to investigative teams, end-users (faculty and staff), and subject-matter experts.

• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Master’s Degree in Health Science, Public Health, Epidemiology, Computer Science, Statistics, Mathematics, or related field.

• Experience with electronic data capture systems in clinical trials.
• Experience with SQL Server administration; WordPress, HTML, CSS.

Classified Title: Research Data Manager
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $48,000 - $84,000 Annually (Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
Exempt Status:Exempt
Location:Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine