Join the HJF Team!
HJF is seeking a Clinical Data Manager II to support the Infectious Disease Clinical Research Program (IDCRP) in Rockville, Maryland. HJF provides scientific, technical and programmatic support services to IDCRP.
The Clinical Data Manager II is responsible for managing and coordinating all aspects of the data management process in support of research activities within the IDCRP. The incumbent will be a member of the Data Coordination Center, which is responsible for providing data processing and analytical support to the IDCRP. Responsibilities include study planning, development of CRFs and other data collection instruments, coordination of other DCC study team member activities, development and maintenance of the data management plan, data entry guidelines and coding manuals, generation and distribution of reports and data forms, data validation and data clarification resolution, and site training as needed for specific studies..
- Interact with Clinical Research Managers and Principal Investigators to assess study needs and plan study activities
- Lead a multi-functional team of data-related resources including data system programmers, data entry clerks, and SAS and Oracle programmers.
- Work with project management staff to define timelines of assigned studies to ensure study milestones are met.
- Represents Data Management (and the DCC generally) during study team meetings, regularly informing project management of overall study data status and potential issues for resolution.
- Work with project management and DCC study team to determine data to be collected and to develop data collection instruments, including annotated documentation.
- Develop and maintain study-specific Data Management Plans.
- Develop and maintain study-specific Data Cleaning and Validation Plans.
- Develop other study-specific documentation manuals including data entry instructions and guidelines, coding manuals and Standard Operating Procedures, as needed.
- Perform EDC data collection instrument User Acceptance Testing.
- Record the receipt, track and distribute research documents through the data management and verification process in a timely and accurate fashion.
- Maintain files for storage of research documents.
- Generate and distribute reports as necessary. This includes batch reports run on daily, weekly, and monthly cycles, status reports as well as any special purpose ad hoc reports.
- Manage query submission, tracking and resolution for single complex studies or group of studies under direction of more senior data managers.
- Review study databases for incomplete/missing data and other data issues.
- Oversee the activities of other DCC staff assigned to manage studies.
- Reconcile discrepancies and obtains guidance when values are questionable or illegible.
- Interact with clinical personnel to resolve omissions, discrepancies or any other data management issues.
- Mentor junior Data Managers on standards, DM practices and Quality Assurance practices.
- Generate, distribute, track, enter resolution, annotate and file data entry reconciliation reports and data clarifications.
- Verify computer-generated output against original data.
- Check work for accuracy on a daily basis according to established procedures.
- Report any system/data errors and/or problems to their supervisor.
- Assist clinical users in database interaction as necessary, performing queries upon supervisor’s direction.
- Adhere to a policy of strict confidentiality concerning all documents, data, and information maintained within the department.
- Adhere to department Standard Operating Procedures for all data management responsibilities.
- Perform other duties as required.
Required Knowledge, Skills and Abilities:
- Proficiency in the understanding, development, and execution in all aspects of clinical trial Data Management (e.g. CRF design, data entry instructions, data management and QA plans, resource planning, data status tracking, etc).
- Ability to manage multiple studies of medium complexity or size concurrently.
- In-depth knowledge of Good Data Management Practices, as defined by the Society for Clinical Data Management.
- In-depth knowledge of Good Clinical Practices, FDA, and ICH related regulatory requirements and terminology for clinical studies performed within the IDCRP.
- Experience using at least one clinical data management system (e.g. RedCap, OpenClinica, Medidata Rave, Oracle InForm, Oracle Clinical).
- Ability to work independently, as part of a team setting, and meet deadlines.
- Excellent verbal and written communication skills, good organizational, interpersonal skills, and demonstrated ability to take the lead on projects.
- Ability to learn new systems necessary for job completion such as Mi-Forms and DB Visualizer.
- Customer-oriented outlook.
- Must be detail oriented; possess problem solving skills, and the ability to handle multiple tasks and set priorities appropriately.
- Adaptable to changes in work duties, responsibilities, and requirements.
Minimum Education Requirements: Bachelor's or equivalent experience with a concentration in the research field. Experience may be substituted for education.
Minimum Experience: 5+ years Data Management experience in a clinical research environment, with at least 2 years’ experience as a Data Manager. Education may be substituted for some experience.
Physical Capabilities: Job performance requires long periods of sitting at a computer. Must possess adequate vision and manual dexterity for computer work. Must have the ability to communicate verbally and move within the work site.
Supervisory Controls: The incumbent will be under the supervision of the Data Management Team Lead.
Work Environment: General office environment.
Background: Eligibility to obtain a Common Access Card (CAC); eligibility to obtain and hold a Public Trust background.
- Work is performed entirely in support of a Federal sponsored Cooperative Agreement and therefore is dependent solely on the ability of the Federal Government to fund the agreement. Position will terminate in the absence or withdrawal of Federal funds.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.