Clinical Trials Manager I (NCI) - Frederick, MD | Biospace
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Clinical Trials Manager I (NCI)

Leidos Biomedical Research, Inc.

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Location:
Frederick, MD
Posted Date:
6/29/2017
Position Type:
Full time
Job Code:
638316
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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) provides comprehensive, dedicated project management and clinical research to the National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC) for development of therapeutic and vaccines products, diagnostics, assays, and immune correlates leading to protection against flaviviruses, including Zika, advancing countermeasures protecting against flavivirus infection.

KEY ROLES/RESPONSIBILITIES
The Clinical Trials Manager I:
Serves as one of the CMRP project leads
Assists with the planning and implementation of clinical trials
Participates in managing and coordinating project activities for the Zika Phase IIB clinical study (and others)
Acts as a liaison between various Leidos Biomed, NIAID entities and collaborating offices, interacting with both scientific and administrative officials
Coordinates and communicates efforts within the assigned activities to include organizing, planning, executing, reporting and evaluating the assigned program objectives
Collaborates with Clinical Research Organizations (CROs) on site management activities
Identifies and assesses clinical trial sites and the necessary infrastructure to carry out clinical studies domestically and internationally, including: clinical site assessment, clinical site preparation, clinical site training and clinical site logistical support
Coordinates meetings between various CROs and clinical sites
Reviews sponsor protocol edits and Informed Consent Form (ICF) edits, case report forms, study templates and manual of operations
Assists with CMRP site audits as needed
Travels up to 20%
This position is located in Frederick, Maryland

Requirements

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 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
A minimum of six (6) years related experience in a pharmaceutical, biotechnology and/or clinical environment
Clinical trial project management experience
Experience in preparing site management budgets
Proficiency in all functions of clinical research implementation processes and conduct
In-depth knowledge of the clinical trial and drug development process
Experience in data management and subcontracting
Ability to work in a clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data
Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCP)
Knowledge of clinical trial fieldwork concepts and practices
Strong customer focus with the ability to communicate effectively, both verbally and in writing
Strong problem solving, planning and organizational skills
Ability to prioritize multiple tasks and projects
Must be able to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS:
Candidates with these desired skills will be given preferential consideration:
Infectious disease research experience
Knowledge of Quality Assurance/Quality Control processes
Knowledge of site selection activities and tracking site capabilities
Fluency in Latin American Spanish and Brazilian Portuguese
Progressively increasing clinical site monitoring/auditing experience, management of multiple concurrent clinical trials/projects and supervisory experience