Clinical Data Manager

CLINICAL DATA MANAGER AT

Baltimore Research and Education Foundation

VETERANS AFFAIRS COOPERATIVE STUDIES PROGRAM COORDINATING CENTER, PERRY POINT MARYLAND

(

PAY:

GS 9-11)

ABOUT US

The Baltimore Research and Educational Foundation (BREF) is a non-profit corporation that supports the mission of the Veterans Affairs Maryland Healthcare System (VAMHCS) by administrating and facilitating biomedical research and education endeavors, particularly those funded by non-VA sponsors. In this capacity, BREF employs research staff and provides other related services for conducting clinical research at the Cooperative Studies Program Coordinating Center in Perry Point, Maryland (CSPCC-PP). The

CSPCC-PP

executes multicenter clinical trials and other types of research under the Dept of VA Cooperative Studies Program, as well as trials and research done under agreements with non-VA (external) funders.

GENERAL JOB SUMMARY

We are seeking a full-time Clinical Data Manager to ensure the integrity, accuracy, and compliance of clinical trial data for assigned studies. This role is critical to the success of our research operations and involves managing data systems, developing study-specific plans, and leading quality control efforts.

JOB DUTIES AND RESPONSIBILITES

• Ensure data integrity and compliance with established standards for assigned studies.
• Manage data capture, editing, and transfer activities, monitoring timelines to meet deadlines with quality.
• Develop and validate study databases, including specifications and user acceptance testing (UAT).
• Lead data validation and quality control efforts, perform audits, and generate site-specific reports.
• Troubleshoot operational issues using metrics, audit reports, and team input.
• Develop programming for study setup, including user interfaces, edit checks, randomization, and reporting.
• Author and maintain Data Management Plans and related documentation.
• Collaborate on study materials, including protocols, CRFs/eCRFs, and risk assessments.
• Perform software application development to support trial databases and reporting needs.

TRAVEL:

• Occasional travel to Baltimore MD, or Washington DC as needed and to other locations to attend center meetings, retreats, and/or center-wide training.

COMPETENCIES

• : treats people with respect; inspires the trust of others; works with integrity and ethically; upholds organizational values
• : Follows BREF policies and procedures; completes administrative tasks correctly and on-time; supports BREF goals and values; supports and respects community, diversity, and inclusion.
• : prioritizes and plans work activities; uses time efficiently; plans for additional resources as needed; sets goals and objectives; develops realistic action plans.
• : approaches and interacts with others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments. Seeks training and education to improve knowledge and skills.
• : Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
• : Demonstrates punctuality; follows instruction and responds to supervisory or management direction; takes responsibility for own actions; keeps commitments; commits to work and time necessary to reach goals; completes tasks on-time or notifies supervisor or appropriate person with an alternative plan.

EDUCATION, EXPERIENCE, QUALIFICATIONS

• Must be legally eligible to work in the U.S.
• Employment is contingent upon successful completion of a background check and fingerprinting
• Bachelor's degree is required
• Minimum of 1 year of experience in data management is required
• Additional education may be substituted for required experience, and additional related experience may be substituted for required education
• Advanced knowledge in .NET programming, and programming in scripting languages, such as, C#, VB script etc., and in Structured Query Language (SQL) and SAS
• Experienced in setting up clinical studies in a clinical data management system (e.g., DataFax or DFdiscover, MediData Rave, Redcap, etc.)
• Familiarity with various data management system utilities, such as, edit check tool, setup tool, configuration tool, reporting tool etc.
• Excellent organizational and problem-solving skills, including anticipating needs and issues
• Excellent attention to detail, accuracy, and deadlines
• Ability to interact effectively with faculty, staff, administrators, federal agencies, and sponsored program personnel at other institutions
• Excellent written, oral, and interpersonal communication skills
• Excellent reading, listening, editing, and analytical skills

WORK ENVIRONMENT AND HOURS

• Work will be performed in-person at the offices of the CSPCC Perry Point MD.
• 40 hours/week, Monday-Friday
• Pay is salary (exempt)

SUPERVISION

: Position reports directly to the Chief, Data Management of the CSPCC in Perry Point, Maryland. In the absence of the Chief, Data Management of the VA CSPCC-PP, the position reports to the Director of the

CSPCC-PP. 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 will be based upon the candidate's education and training pertinent to the Clinical Data Manager duties. Benefits include health care, life and long-term care insurance, a 403(b) retirement program, annual and sick leave. If interested in applying for the Clinical Data Manager position, please send a cover letter describing your interest in the position and your resume.

Pay:

$68,013.00 - $90,520.00 per year Ability to

Commute:

Perry Point, MD 21902 (Required)

Work Location:

In person