SSS, a DLH Corporation company, serves federal government clients throughout the United States and abroad delivering technology enabled solutions in key health and human services programs. The Company's core competencies include secure data analytics and statistics, clinical trials and laboratory services, a full suite of public health research offerings, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has over 2,000 employees serving numerous government agencies. DLH’s portfolio consists of Defense & Veteran Health Solutions, Human Services Solutions and Public Health & Life Sciences.
The Data Manager (DM) works closely with the multidisciplinary project team across the lifecycle of the study to ensure data management is thoughtfully planned and delivered in a consistent, timely and high-quality manner. The DM is a key contributor to project success through development and utilization of innovative tools to help automate manual tasks and identify data trends in a timely fashion and in collaboration with project peers, i.e. biostatisticians, statistical programmers, and clinical operations personnel. The DM also independently performs and oversees completion of data management tasks to ensure that the clinical database design supports study outcomes; proactively monitors and cleans clinical data so as to mitigate risks; effectively communicates data-related problems and proposed solutions to investigators; and ensures that data management activities follow all currently applicable industry and regulatory standards and study-specific procedures.
Provides leadership in devising and designing data management processes which will support high integrity and quality of each study. Manages database design, development, testing, and validation for new studies. Has the expertise to work independently and mentor/lead others in these tasks. Provides technical expertise for developing, monitoring, and maintaining multiple databases or applications and diagnoses and resolves data management problems and issues.
Responsible for data management activities for clinical studies, including the following:
- Implements setup of study database, maintenance, and closeout activities for clinical studies. Setup activities may include CRF design, database structure design support, CRF annotation, project document creation and review, data entry screen design and testing, validation check creation, testing and approval.
- Leads design of eCRF and reviews to ensure that design is robust and minimizes risk. Works closely with lead statistician to translate study outcomes and protocol specifications into eCRF design; works with programmers to develop eCRFs; and coordinates user acceptance testing and approval process.
- Creates, monitors, and maintains timelines for data management tasks.
- Uses data reporting tools and programs (e.g. SAS, R, Tableau, etc.) to identify and report current or potential data entry or study implementation problems to study and data management team members, develops and implements solutions.
- Oversees and/or enters research data, reviews data to ensure accuracy, and corrects discrepancies using appropriate data collection tools.
- Writes procedural and work instruction manuals, data collection guidelines, and standard operating procedures and ensures that the data management team is compliant with the procedures.
- Writes study-specific data management plans that address areas such as data coding, reporting, transfer, data archive, and work flow processes.
- Conducts training for the study team on data collection and management practices and guidelines.
- Cleans study data and reconciles data from multiple sources; using data cleaning tools (as noted above) to identify data trends and potential issues early in the study life-cycle, and designs/implements intervention plans to address issues. Holds multidisciplinary data reviews for trends and anomalies and to proactively address risks.
- Generates reports, summaries, and listings of study data and conducts data monitoring using SAS, R, and/or MS Excel.
- Establishes and maintains database standards, procedures and guidelines and participates in the planning of future database expansion, enhancements, and selection. Analyzes, reviews, and recommends upgrades for existing databases. Provides support on database and file accessing techniques, search strategies, processing, and space utilization efficiencies, database security procedures, backup and program recovery techniques, and testing techniques.
- Documents, tracks, and resolves user questions and problems for the full range of the client’s research software. Identifies and solves hardware, software and operational errors; and determines which problems must be forwarded to the appropriate software support person or vendor representative. Works with vendors to resolve technical problems.
- Researches, evaluates, introduces, and supports new evolving technologies potentially of use to the end user community and develops logical data models to be translated into workable physical database designs to accommodate new business requirements and processes. Participates in the evaluation of specifications and features of new products, performing product comparisons, feasibility and cost benefit analyses, and performance and compatibility testing, and makes recommendations for future implementation.
- Documents and participates in meetings, conferences, and stakeholders meetings related to research areas.
- Communicates clearly and collaborates directly with study investigators, managers, study team members, and monitors.
- Supervising and mentoring of junior data management staff as needed
- Performs additional duties as required.
- Bachelor's degree with at least 5 years of relevant experience. Strong proficiency with MS Office.
- Experience with statistical programming software such as SAS or R.
- Excellent working knowledge of clinical studies and the data management role in the clinical research process.
- Experience with relational databases and electronic data capture (EDC) systems such as Medidata RAVE.
- Excellent verbal and written communication skills; strong analytic and organizational skills, and excellent attention to detail. Able to work well in team environment and independently.
- Ability to efficiently plan, prioritize, and implement workflow and procedures.
- Knowledge of medical terminology preferred; knowledge of SDTM a plus.