Clinical Project Manager II
Job ID: req1622
Employee Type: exempt full-time
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 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.
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, tuberculosis, malaria and other infectious diseases and viruses such as hepatitis C 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) provides specialized support services for initiatives in support of the National Cancer Institute (NCI). CMRPD is responsible for establishing and maintaining clinical trials regulatory and auditing support services for the NCI DCP US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet). This position may support various institutes of the NIH.
Responsibilities include but are not limited to:
- Provides clinical operations and regulatory management for domestic and international clinical trials
- Support regulatory affairs planning and execution in ULACNet to advance investigational agents through investigational studies and approval processes, including participation in and preparations for pre-IND meetings and the preparation of IND submissions.
- Assist in the development and review of clinical trial protocols, informed consent documents, investigational plans, Investigator Brochures, nonclinical and clinical data summaries, manufacturing information, and safety monitoring procedures.
- Assist in the compilation of regulatory documentation (e.g., nonclinical reports, Investigator Brochures, CMC) for compliance with applicable regulations and pertinent guidance.
- Support the preparation, tracking, and submission, and maintenance of regulatory documents, filing amendments, and undertaking correspondence with regulatory authorities.
- Support the preparation of submissions to relevant Institutional Review Boards and in-country regulatory oversight agencies.
- Support development of timelines for the drafting, review and submission of regulatory information, and working with key contributors and regulatory production team to ensure timely compilation of reports and submissions and communication of status to project team and external stakeholders.
- Communicate and collaborate effectively with multidisciplinary group of stakeholders and colleagues.
- Manages project risk by proactively anticipating obstacles and developing contingency plans and solutions
- Participates in budget development, cost estimating and forecasting
- Maintains extensive knowledge and understanding of international and domestic clinical research regulations and compliance requirements
- Reviews and/or develops progress reports, operational processes, procedures, and documents required to manage regulatory aspects of projects effectively, including study planning, start up, implementation and close out
- Provides input for training materials for delivery to research staff and study teams on conference calls and in-person at investigator meetings
- May manage subcontractors including the development of Statements of Work, review and approval of deliverables, review of invoices, and monitoring of scope and budgets
- May supervise other operational project staff, and may be asked to perform other related duties as assigned by a responsible authority
- Position may travel 15% domestic and international
- Position is located in Frederick, Maryland
- Possession of 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 or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, a minimum of eight (8) years of progressively responsible, relevant experience in clinical research, including a minimum of three (3) years directly managing multiple concurrent clinical projects
- Extensive experience in regulatory compliance management and reporting including experience as a Regulatory Associate or Regulatory Specialist.
- Previous project management and/or study coordination experience including regulatory submissions and reporting
- Direct experience in drafting, filing, and maintaining applications with FDA.
- Experience related to clinical operations (e.g., development of Standard Operating Procedures [SOPs], staff development and training, resourcing/staffing, and budget planning and execution)
- Strong skills in MS Word, Excel, and Outlook.
- Ability to obtain and maintain a security clearance
Candidates with these desired skills will be given preferential consideration:
- Fluency in Spanish and/or Portuguese
- Clinical Research or Project Management Professional with infectious disease experience
- Clinical operations experience at a CRO or Sponsor
- Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs) ICH, and relevant regulatory agency requirements domestically and internationally.
- Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
- Knowledge of electronic Common Technical Document (eCTD) submission format preferred.
- Knowledge of the development of electronic Trial Master Files
- Familiarity with the management and shipment of study products and supplies
- Familiarity with Federal Acquisition Regulations (FAR) and experience conducting federally funded research studies
- Experience in overseeing the work of subcontractors and/or vendors
- Knowledge of Microsoft Project, Smartsheet or other project tracking software
- Must be detail-oriented and possess excellent skills in prioritization, problem solving, organization, decision-making, time management and planning
- Exceptional written and oral communication skills to work closely with numerous stakeholders from diverse organizations, attend meetings as a program liaison, and keep track of meeting minutes
- Ability to work in a clinical research setting both independently and within a team
- Ability to work diplomatically with regulatory agencies within complex international environments
- Demonstrated success in previous positions in deployment and implementation processes
- SoCRA or ACRP certification is a plus
- Ability to travel internationally
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)