Clinical Data Management Supervisor in Rockville, MD

Description

Clinical Data Management Supervisor

Job ID: req1605
Employee Type: exempt full-time
Facility: Rockville: 9605 MedCtrDr
Location: 9605 Medical Center Drive, Rockville, MD 20850 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest.  

 Position Overview:

PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale. 

The Clinical Monitoring Research Program Directorate (CMRPD)/Clinical Trials Reporting Office (CTRO) supports the NCI's Clinical Trials Reporting Program (CTRP), which maintains a database of information on NCI-supported clinical trials. The CTRO team creates and maintains clinical trial summary records in the CTRP database. These records serve the NCI for portfolio analysis purposes and they are the source for information used to support the cancer research grants review process. Some of the clinical trial information that the CTRO abstracts is fed to public clinical trial search websites including Cancer.gov and ClinicalTrials.gov. 

KEY ROLES/RESPONSIBILITIES

• Supervises a team of clinical data abstractors responsible for creating and maintaining summary reports of clinical trials funded by the NCI
• Reviews the team's summary reports and ensures that they accurately and consistently represent clinical trial protocols and related documentation
• Ensures the team meets the contract expectations for trial summary report turnaround time (under 10 business days)
• Leads quality assurance activities, monitors staff performance, and coaches under-performing personnel
• Coordinates orientation, training, and team-building activities for staff
• Celebrates team achievements and reports activities
• Conducts periodic performance reviews; helps team members to set and achieve goals
• Ensures timely and accurate responses to inquiries submitted to the CTRO
• Reviews feedback from diverse sources and addresses areas requiring data update or process improvement
• Manages team data update and outreach projects; ensures timelines are accurately set and maintain communication with stakeholders
• Fully investigates issues to be escalated to leadership and provides recommended actions
• Participates in high-level meetings to support customer goals, clarifies expectations, and addresses concerns
• Collaborates with stakeholders to facilitate the structuring of trial eligibility criteria to support matching of participants to clinical trials
• Participates in stakeholder meetings; proposes and speaks to meeting agenda topics
• Efficiently troubleshoots and reports unexpected technical problems
• Collaborates with developers to propose system enhancements and performs user acceptance testing of new features
• Handles special requests or other duties in support of CTRP, as assigned
• This position is located in Rockville, Maryland 

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health (Additional qualifying experience may be substituted for the required education).  Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of four (4) years of job-related experience and one (1) year as a Lead or Supervisor
• Experience in clinical trial reporting, medical writing and/or clinical research
• Knowledge of clinical trial designs and protocols, especially in the field of oncology
• Experience with oncology structured clinical trial eligibility criteria
• Understanding of clinical trial search interfaces and patient trial matching
• Knowledge of cancer terminology, staging, and biomarkers
• Understanding of clinical trials reporting requirements and Food and Drug Administration Amendments Act (FDAAA) of 2007
• Experience with issue tracking systems and process documentation
• Must be able to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

• Exceptional written and oral communication skills
• Able to lead a team in a fast-paced environment
• Demonstrated clinical experience and/or in-depth knowledge of clinical trials
• Must be detail-oriented with a proactive approach
• Able to independently prioritize multiple projects/tasks and reliably meet deadlines
• Proficient with Microsoft Outlook and Excel
• Able to translate clinical information for a lay audience
• Able to collaborate in a multifunctional team environment
• Willingness to perform tasks that may fall outside of the normal daily responsibilities

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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