Clinical Project Manager I
Job ID: req3695
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
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.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
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 for initiatives and special projects in support of the National Cancer Institute, Division of Cancer Prevention (DCP). CMRPD is responsible for providing clinical trial support services to NCI/DCP global clinical research studies. The CMRPD provides comprehensive clinical trials management and oversight support to the various clinical research initiatives of the NCI/DCP. This position may support various institutes of the NIH.
Responsibilities include but are not limited to:
- Provide project management support for the implementation and day to day operations of a central coordinating center, including development of SOPs and guidance documents
- Provide programmatic support for the implementation and management of domestic and international clinical trials at selected clinical research sites as needed
- Maintain coordination and communication between research operations, program management, project stakeholders and team members, and act as a liaison between government customers and subcontractors on behalf of CMRPD
- Work closely with program and project leadership to implement the clinical trials, including developing overarching project plans with scope and timelines, setting expectations for operational performance of subcontractors
- Assist in the review of clinical trial protocol and informed consent documents
- Support the preparation, tracking, and submission, and maintenance of program documents, filing key documents, and facilitating contract required reporting
- Support development of timelines for the drafting, review, and submission of program information, and working with key contributors 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
- Manage project risk by proactively anticipating obstacles and developing contingency plans and solutions
- Participate in budget development, cost estimating and forecasting
- Maintain extensive knowledge and understanding of international and domestic clinical research regulations and compliance requirements
- Review and/or develop project management tools, operational processes, procedures, and documents required to manage operational aspects of projects effectively, including project planning, start up, implementation, tracking and close out of the project
- Provide input for training materials for delivery to research staff and study teams on conference calls and remote and in-person at investigator meetings
- Manage subcontracts, clinical trials agreements and other agreements, including the development of Statements of Work, review and approval of deliverables, review of invoices, payments, and monitoring of scope and budgets
- Supervise other operational project staff, and may be asked to perform other related duties as assigned by a responsible authority
- Position may travel 5% domestic and international
- Position is remote.
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
- In addition to educational requirements, a minimum of five (5) years of progressively responsible, relevant experience in clinical research, including a minimum of three (3) years directly managing multiple concurrent clinical projects
- Previous project management and/or clinical trials or study coordination experience including regulatory submissions and reporting and research subcontracting
- Experience in contract/subcontract management
- Extensive experience in reporting and change management
- Previous Project Experience related to clinical operations (e.g., development of Standard Operating Procedures [SOPs], staff development and training, resourcing/staffing, and budget planning and execution)
- Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs) ICH, and relevant regulatory agency requirements domestically and internationally.
- Experience in overseeing the work of subcontractors and/or vendors
- Ability to work in a clinical project management/research setting both independently and within a team
- Must be detail-oriented and possess excellent skills in prioritization, problem solving, organization, decision-making, time management and planning
- Strong skills in MS Word, Excel, and Outlook
- Must be able to obtain and maintain a clearance
Candidates with these desired skills will be given preferential consideration:
- Clinical Research or Project Management Professional with oncology experience
- Clinical operations experience at a CRO or Sponsor
- Previous work with clinical trials agreements: negotiating, invoice reviews etc.
- Previous work with negotiating subcontracts with IRBs for centralized IRB activities
- Previous Project Management work with data management activities
- Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
- Familiarity with Federal Acquisition Regulations (FAR) and experience conducting federally funded research studies
- Knowledge of Microsoft Project, Smartsheet or other project tracking software
- 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
- Demonstrated success in previous positions in deployment and implementation processes
- SoCRA or ACRP certification
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.