Clinical Data Management Manager (NCI)

Location
20850, Rockville
Posted
May 31, 2018
Ref
653506
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

PROGRAM DESCRIPTION

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) 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 Institute of 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, CMRP’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. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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.  CMRP’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 (CMRP) Collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. 

KEY ROLES/RESPONSIBILITIES

  • Serve as the main contact for NIAID laboratories on data management products and deliverables
  • Preserve strong relationships with NIAID laboratories and internal team members through open, efficient and timely communications
  • Responsible for developing, review and change control of Case Report Forms (CRF)
  • Ensures review and quality control against associated project protocol, NIAID laboratory requirements, CRF standards templates, Good Clinical Data Management Practices (GCDMP), and where applicable CDISC Clinical Data Acquisition Standards Harmonization (CDASH) standards
  • Plan and lead database setup with NIAID laboratories, ensuring appropriate database documenting
  • Perform database validation as well as User Acceptance Testing (UAT), and document databases in accordance with programming standards and validation procedures
  • Responsible for setup and review of Data Management documentations clearly outlying the project data management processes
  • Responsible for monitoring data management operational activities through quality control procedures, identifying individual as well as systemic data anomalies, as well as institution of corrective and preventative action plans (e.g. additional edit checks, data monitoring reports and/or listings, email alerting, etc.)
  • Understand and comply with Good Clinical Practices (GCP), SOPs, Regulatory requirements and GCDMP
  • Meet objectives as assigned and interact with the NIAID project teams to organize timelines, responsibilities and data management deliverables
  • Developing, implementing, testing and quality control of new technologies with guidance from the Clinical Trials Data Management team as well as more experienced team members
  • Develop clinical data management training and mentorship programs as well as present at Clinical Data Management training events and workshops
  • Review and development of Data Management SOP and Clinical Trials Data Management Best practice guidelines
  • Supervise staff

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of a Bachelor’s degree in a related field from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) (Additional qualifying experience may be substituted for the required education) Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the educational requirements, a minimum of six (6) years relevant experience
  • Knowledge of data management processes and systems (specifically clinical data management systems)
  • Understanding of clinical trials and the drug development process
  • Experience, knowledge, or ability to supervise staff members
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Strong clinical data management capabilities
  • Excellent communication skills
  • Experience with supervision of data management and data entry staff

Expected Competencies:

  • Good written and oral communication skills
  • Leadership and project management skills
  • Good organizational skills