Senior Clinical Data Manager
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Senior Clinical Data Manager
The Office of the Clinical Director (OCD) is responsible for supporting and executing research and administrative aspects of NIAMS Intramural Clinical Research Program initiatives and for advising staff on regulatory issues related to human subjects research protections. The OCD Director implements and monitors a comprehensive clinical research program designed to provide investigators with resources for the efficient and ethical conduct of clinical research.
The Senior Data Manager will be responsible for clinical data management, compilation and standardization of data from multiple and varying sources, creation of case report forms in multiple database platforms, creation of unique queries for data retrieval and analyses, and quality assurance and quality control of NIAMS clinical data housed in multiple databases within a variety of database platforms. The candidate will have expertise in multiple types of data platforms, such as CTDB, LabMatrix, RedCap, CRIMSON, C3D, and others
Responsibilities:
- Assist investigators with creating a presence in databases, such as CTDB, for housing NIAMS clinical data;
- Design and create Case Report Forms (CRFs) for capturing clinical data for housing in databases, such as CTDB;
- Assist Investigators and program teams with database design change requests in databases, such as CTDB, and to CRFs;
- Compile data from various and multiple sources and standardize the data for comparative analyses and housing in a single database, such as CTDB;
- Coordinate with investigators and external sponsors of clinical trials for the creation of data capture and storage systems that will comply with external sponsor requirements; this may require the use of external or non-NIH databases specified by external sponsors, and may require training by the candidate to become proficient in the external databases;
- Ensure proper management of clinical data housed in NIAMS databases, such as CTDB, and ensure standardization of clinical data across multiple research studies and NIAMS programs;
- Perform data abstraction, data verification, Quality Assurance/Quality Control (QA/QC), and run data reports;
- Assist investigators during QA/QC monitoring visits to retrieve and clean data for monitor review;
- Assist investigators during audits by internal and external entities, including NIAMS monitors, NIH OHSRP, NIH ORSC, external sponsors, and regulatory agencies, such as the FDA;
- Coordinate with investigators and study teams to assist with data capture, data process and analysis, and to perform data entry into a variety of NIAMS and external databases;
- Use a variety of advanced software function and database systems, such as CRIS (Clinical Research Information System), BTRIS (Biomedical Translational Research Information System), ACCESS, Excel, CTDB, C3D, and external databases stipulated by external sponsors;
- Ensure data security and data quality, trouble-shoot problems, and ensure accurate data transfer among various data systems;
- Organize and track clinical data assignments and report progress to investigators, study teams, and the NIAMS Clinical Operations Manager;
- In coordination with study teams (Study coordinators), track and record Adverse Events (AEs), including Serious Adverse Events (SAEs) and Unanticipated Problems (UPs) and Problem Reports (Incident Reports) to the NIH IRB and other regulatory entities, such as external sponsors and the FDA;
- Prepare internal reports, including incident reports and summaries and responses to stipulations and recommendations resulting from monitoring visits and audits;
- Use varied and advanced functions of word processing software (MS Office) to prepare and finalize written documents as described above;
- Draft Standard Operating Procedures (SOPs), guidelines, and checklists relating to data capture and QA/QC best practices for use by investigators and study team members;
- Advise investigators and study team members on ways to improve work flows and data capture and data management practices;
- Attend study team meetings and actively participate in study team planning sessions; and
- Conduct other data management duties when requested by investigators and study team members.
Requirements:
- Bachelor’s degree or equivalent;
- Minimum of five years’ experience in clinical data management;
- Minimum of two years’ experience in clinical data management at the NIH;
- Experience with and expertise in the following databases and data platforms: ACCESS, CRIS, BTRIS, CTDB, and C3D;
- Experience with clinical data management for clinical biomedical research, clinical epidemiological studies, natural history and observational studies, NIH-sponsored clinical trials, external-sponsored clinical trials, and FDA-regulated IND clinical trials;
- Expertise in creating a database presence, including creating forms, queries, and a data capture and/or transfer plan, for multiple databases, such as CTDB, C3D, RedCap, and LabMatrix;
- Expertise in creating Case Report Forms (CRFs) in a variety of databases, such as CTDB, C3D, RedCap, or LabMatrix;
- Excellent writing skills, communications skills, and experience in writing reports, such as responses to monitoring visit stipulations, responses to internal and external data calls, and summary reports for annual reviews;
- Experience in drafting Standard Operating Procedures (SOPs), guidance documents, instruction documents, and checklists for study teams in order to assist in accurate data capture and data entry, and to ensure data management best practices;
- Experience with providing data management support to teams for monitoring visits and audits, providing responses to stipulations and recommendations, and implementing changes to data processes and systems in response to monitoring visit and audit stipulations and recommendations;
- Experience with performing Quality Assurance/Quality Control (QA/QC) of data housed in a variety of systems and platforms, such as CTDB, C3D, RedCap, and LabMatrix;
- Experience with documenting and reporting adverse events (AEs) and serious adverse events (SAEs), including data breaches and other protocol deviations and non-compliance events related to clinical data management;
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