Clinical Quality Management Manager (NCI)

Location
Bethesda, Maryland
Posted
Oct 18, 2017
Ref
642939
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) provides oversight for domestic and international audits/inspections ensuring compliance with the FDA and other worldwide health authority regulations/guidelines, standard operating procedures, protocols, and industry standards relating to GCPs.

KEY ROLES/RESPONSIBILITIES

Develops and oversees a comprehensive pharmacovigilance system to review ongoing safety reporting efforts for VRC sponsored clinical studies. The system will include: evaluation of the timeliness of reporting serious adverse events to regulatory agencies, ensure regulatory compliance and safety throughout the trial, assist with internal and external drug safety audits, remediate any pharmacovigilance deficiencies found during regulatory or internal audits, establish and maintain consistency of safety assessments within the US and outside the US, identify the corrective and preventative actions and facilitate, support and implement them as appropriate, review performance metric data and clarify inconsistencies and trends

 

  • Reviews and provides input on new protocols, protocol amendments, consent forms, study data collection forms/source documents, case report forms, procedure manuals, and other study related documents
  • Reviews and provides input on CRO developed risk-based clinical monitoring plans
  • Provides oversight of site selection and qualification activities to ensure that the clinical site is adequate and the site staff is qualified to execute the clinical trial within established timelines
  • Develops and/or reviews training materials for site initiation and planning
  • Participates in site initiation visits or Investigator meetings
  • Provides oversight of CROs to ensure that all required regulatory documents are on file with the site and sponsor prior to study start and throughout the clinical trial
  • Ensures proper conduct of clinical trial by reviewing CRO monitoring activities during the trial and activities are executed in accordance with the approved Clinical Monitoring Plan
  • Establishes regular lines of communication with assigned monitors and other CRO staff throughout the planning and execution of the trials
  • Assists in resolving clinical trial issues escalated to the Sponsor and ensuring that adequate corrective and preventive actions are developed, executed, and documented
  • Continuously reviews clinical trial quality and intervenes when issues arise that affect quality
  • Manages/monitors study progress by tracking study metrics and communicating to stakeholders
  • Provides oversight of CRO monitors to ensure that all required documentation is archived appropriately and any IP/samples at the site are shipped, disposed of, and/or accounted for per Sponsor requirements
  • Works in a hands-on capacity to promote a culture of quality
  • Works both independently and in a collaborative team setting and successfully builds relationships with internal teams and external stakeholders
  • Manages projects of significant scope and complexity, while meeting all deliverables and timelines
  • Develops quality policies, procedures, and standards which will govern VRC medical research programs utilizing Good Clinical Practices (GCP)
  • Serves as an advisor to the Office Director on all matters involving regulatory compliance and quality management
  • Assists the product development teams with impact/risk assessment from issues, failures and deviations during clinical studies (this may include the conduct of after action reviews to ensure continual process improvement)
  • Responsible for developing systems and strategies to evaluate the conduct of FDA sponsor responsibilities by the VRC which includes developing a pharmacovigilance oversight system, conducting/overseeing audits, reviewing compliance plans, conducting training, and developing SOPs for VRC regulatory activities
  • May be responsible to supervise staff
  • Travels up to 10%

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 eight (8) years of progressively responsible relevant experience in clinical research including a minimum of six (6) years directly managing multiple concurrent clinical projects
  • Must be able to obtain and maintain a security clearance

 

PREFERRED QUALIFICATIONS:

Candidates with these desired skills will be given preferential consideration:

 

  • Certified IRB or Clinical Research Professional (CRP)
  • Infectious disease and vaccine research experience
  • Knowledge of Quality Assurance/Quality Control processes
  • Knowledge of site selection activities and tracking site capabilities
  • Progressively increasing clinical site monitoring/auditing experience, management of multiple concurrent clinical trials/projects and supervisory experience
  • Ability to read, speak, and write – Latin American Spanish and/or Brazilian Portuguese

 

EXPECTED COMPETENCIES:

 

  • International clinical trials experience
  • Clinical trial project management experience
  • Experience in preparing and managing 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