Clinical Research Data Manager

CLINICAL RESEARCH DATA MANAGER, EXTERNALLY FUNDED RESEARCH PROGRAM

AT

VA COOPERATIVE STUDIES COORDINATING CENTER, Perry Point, Maryland

and

Baltimore Research and Education Foundation

Position: Clinical Research Data Manager (In-person position)

Organization: Baltimore Research and Education Foundation and Department of Veterans Affairs Cooperative Studies Program

Location: Baltimore, Maryland

Position Type: Full-time, Hybrid Telework Eligible but this position is not 100% Remote!

About Us:

Baltimore Research and Education Foundation (BREF), one of many U.S. Congress mandated biomedical research non-profit corporations in the United States, is affiliated with the Veterans Affairs Maryland Healthcare System (VAMHCS) and located in Baltimore, Maryland. Established in 1990, BREF provides a mechanism to conduct externally funded clinical research in the VA system by administering and facilitating biomedical research endeavors funded by non-VA sources such as non-VA federal agencies, industry, foundations, and private donors. BREF provides a variety of services to support VA Research, such as employing research personnel, executing and administering grants and contracts, and managing research project financial activity.

VA Office of Research and Development (ORD) is the U.S. Department of Veterans Affairs home for a large biomedical research enterprise which funds, manages, coordinates, and evaluates discovery and innovation that promotes care and health of veterans. ORD is in Washington DC.

The Cooperative Studies Program Coordinating Center (CSPCC) at Perry Point, Maryland executes multicenter clinical trials and other types of research under the VA ORD Cooperative Studies Program, as well as trials and research done under agreements with non-VA (external) funders such as NIH.

Externally Funded Research Programs (EFRP) of the CSPCC at Perry Point, Maryland, currently includes execution of clinical trials/research studies under two Interagency Agreements (IAAs) – one between VA ORD and the National Institute of Allergy and Infectious Diseases (NIAID) and the other one between VA ORD and the National Institute for Drug Abuse (NIDA). Occasional trials from University of Maryland, Baltimore and/or other local universities and institutions also fall under the EFRP. BREF services and employees are utilized to conduct these EFRP activities within the VA system.

Responsibilities:

· Oversee the management and integrity of clinical trial data within the Program.

· Coordinate data collection, processing, and analysis activities according to regulatory standards and organizational guidelines. This includes:

o translating clinical trials protocols into data specifications

o assisting in the development of data collection tools (CRFs/eCRFs)

o applying simple logic and range checks on data received

o executing user acceptance testing (UAT)

o performing automated and manual routine data reviews

o resolving queries on incongruent data

o preparing datasets for internal analysis/reporting

o training, troubleshooting, and supporting end users of the system

o reporting bugs to the Clinical Data Programmer

· Develop and implement data management plans and protocols for clinical trials.

· Ensure compliance with relevant regulatory requirements, including FDA guidelines and Good Clinical Practice (GCP) standards.

· Collaborate with cross-functional teams to support the planning and execution of clinical trials. Perform quality control checks and data validation procedures to ensure accuracy and completeness of clinical trial data.

· Contribute to the development and implementation of data management systems and processes to streamline data collection and analysis.

Essential Skills:

· ability to interact with end users to define systems needs and requirements

· ability to adapt to shifting priorities and adhere to strict deadlines

· excellent organizational, oral and written communications skills

· excellent interpersonal/teamwork aptitude

· understanding of the clinical trials lifecycle is desirable

Desirable Technical Skills: Medidata RAVE or experience in a similar eDC system, C#, VBScipt, .NET, SQL Stored Procedures, SQL Server, Visual Studio, database design, UNIX/PERL scripting.

Qualifications:

· Bachelor's degree in a related field (e.g., Life Sciences, Health Informatics, Biostatistics, etc.). Advanced degree preferred.

· Minimum of 5 years of experience in clinical trial data management.

· Strong understanding of clinical research methodologies and regulatory requirements.

· Experience with Medidata CTMS (Clinical Trial Management System) is a plus.

· Proficiency in data management tools and software, such as SAS, Oracle Clinical, or similar platforms.

· Excellent organizational, communication, and problem-solving skills.

· Ability to work effectively in a team-based environment and manage multiple projects simultaneously.

· Demonstrated commitment to accuracy, attention to detail, and quality assurance in clinical data management.

Work Environment and Hours:

· Generally, work will be performed in-person at the George H. Fallon Federal Building in Baltimore or in offices of the CSPCC Perry Point MD

· THIS IS NOT A VIRTUAL OR REMOTE POSITION. The position is eligible for Telework on occasion or regularly scheduled with supervisor and BREF Executive Director approval.

· 40 hours/week, Monday thru Friday

· Pay is salary (Exempt)

Equal Opportunity Employer: BREF is an equal opportunity employer, thereby ensuring equal opportunity for employment and advancement to all qualified persons without regard to race, color, religion, national origin, sexual preference, lawful political affiliation, marital status, non-disqualifying physical or mental handicap or age.

Salary is commensurate with education and experience. Benefits include health, life, and long-term disability insurance, 403(b) retirement program and annual, sick and holiday leave. If interested in applying for the Clinical Research Data Manager position, please send your resume and a cover letter describing your interest in this position.

Job Type: Full-time

Pay: $80,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• CLINICAL TRIAL DATA MANAGEMENT: 5 years (Required)

Ability to Commute:

• Baltimore, MD 21201 (Required)

Work Location: In person

Salary : $80,000 - $120,000