Clinical Data Manager
- Expired: over a month ago. Applications are no longer accepted.
Job Title: Clinical Data Manager III (Remote) – Military HIV Research Program & Emerging Infectious Diseases Branch
Location: Bethesda, MD (Remote)
Hours: Full Time, M-F
Pay: $72,400 - $115,800/Yearly, DOE
Type of Hire: Direct Hire
Our client is seeking a Clinical Data Manager III to support the Data Coordinating and Analysis Center (DCAC) for the Military HIV Research Program (MHRP) and the Emerging Infectious Diseases Branch (EIDB) of the Walter Reed Army Institute of Research (WRAIR) located in Bethesda, MD. The client provides scientific, technical, and programmatic support services to MHRP & EIDB. Remote option available for this opening.
The Data Coordinating and Analysis Center (DCAC) is an in-house centralized resource for clinical data management, biostatistical analysis, reporting, and training in support of clinical trials and scientific research studies conducted by MHRP and other programs. The Clinical Data Manager will be responsible for overseeing all aspects of the data management process in support of projects including: data collection document instrument design; document control and storage; development, testing, and maintenance of database screens; development and maintenance of data entry guidelines and coding manuals; data reconciliation and cleaning; creating research data sets; entry level data analysis (descriptive statistics); generation and distribution of reports, tables, and graphics; and, training as needed for specific studies.
NOTE: All employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.
1. Develop, review, store, track, and maintain: data management plans; data entry instructions and coding manuals; Standard Operating Procedures (SOPs); case report forms and case report form annotation; form completion instructions; data entry reconciliation reports; documentation manuals; other department and protocol related documentation. Onboard and mentor other staff in these procedures as required.
2. Design and maintain data entry screens and data management database. Drafts and oversees execution of study validation plan.
3. Interact directly with Principal Investigators, Investigators, Clinical Research Coordinators, and other protocol team members to develop and document DCAC requirements for support of data management as Lead Data Manager.
4. Develop, plan, and coordinate edit check documentation, quality control documentation, and processes as appropriate for complex studies.
5. Manage query submission, tracking and resolution for single complex studies or group of studies, including interacting with clinical personnel to reconcile data discrepancies, generating query reports, obtaining resolutions, and tracking and documenting resolutions.
6. Provide assistance and training to clinical users and data entry personnel when new protocols begin, as new screens are added or modified, and on an ad hoc basis as appropriate.
7. Assist researchers in retrieving information from the databases and other data sources. Generate and distribute reports as necessary. This includes batch reports run on daily, weekly, and monthly cycles; status reports; any special purpose ad hoc reports; and, basic univariate statistical analysis reports.
8. Adhere to departmental Standard Operating Procedures (SOPs) for all data management responsibilities, assist in creation of SOPs, and mentor junior Clinical Data Managers on SOPs including quality assurance practices.
9. Identify potential project risks and corresponding solutions to complex data management requests.
10. Fulfill data management project responsibilities at the level of lead for single complex studies or group of studies.
11. May perform other duties and responsibilities as assigned or directed by the supervisor.
Required Knowledge, Skills and Abilities:
Proficiency in the understanding and execution of all aspects of clinical trial data management; experience with SAS and SQL; demonstrated ability to manage multiple, complex and/or large research studies concurrently; working knowledge of good data management practices as defined by the Society for Clinical Data Management, Good Clinical Practices, FDA, and ICH related regulatory requirements and terminology for clinical studies; experience managing data-related aspects of studies with FDA-regulated substances; working knowledge of at least one clinical data management system (e.g. REDCap, OpenClinica, Medidata Rave, Oracle InForm, Oracle Clinical); must have excellent oral and written communication skills.
Preferred skills include: experience using REDCap; experience with HIV and EID vaccine clinical trials; experience with R, STATA, SPSS, and/or Python; experience with CDISC standards; experience working with INDs.
Minimum Education: Bachelor’s degree required. Master’s degree preferred in Computer Science, Information System Management, Data Science, Public Health, Health Informatics, or related field.
Minimum Experience/ Training Requirements: A minimum of 6-8 years of experience required.
Supervisory Responsibilities: Assigned Lead: May recommend the following: employee hiring, disciplinary action, and starting salaries; provide input on employee performance evaluations.
Work Environment: Office setting - Fully remote or hybrid model available.
Work Arrangement: Fully remote or hybrid model available.
Level One Personnel is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other status protected by law
Level One Personnel aggressively recruits, screens and tests applicants to ensure that only qualified candidates are provided to our clients. We pride ourselves on establishing on-going relationships with our candidates and our clients, allowing us to find the best fit for long-term career satisfaction. By matching the right person with the right job, Level One ensures a win-win situation for business clients and employees.
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