Project Manager I
November 6, 2022
Project Manager I
Job ID: req2703
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
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.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
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, 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. 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 sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) Division of Microbiology and Infectious Diseases (DMID). CMRPD is responsible for the management and oversight of clinical research studies related to COVID-19 and other emerging and re-emerging infectious diseases studies globally. All or a portion of these research studies will be coordinated through a Clinical Research Organization (CRO).
KEY ROLES/RESPONSIBILITIES
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork
Job ID: req2703
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
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.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
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, 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. 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 sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) Division of Microbiology and Infectious Diseases (DMID). CMRPD is responsible for the management and oversight of clinical research studies related to COVID-19 and other emerging and re-emerging infectious diseases studies globally. All or a portion of these research studies will be coordinated through a Clinical Research Organization (CRO).
KEY ROLES/RESPONSIBILITIES
- Provides support to various designated high-profile clinical research projects related to COVID-19 and other emerging and re-emerging infectious disease studies.
- Communicates and interacts with high-level executive, administrative, technical and program management staff, both internally and externally, to gather and compile information for dissemination.
- Contributes to the development of master systems and related processes necessary for tracking, planning and execution of projects and protocol-related materials.
- Maintains communications and documentation between teams involved in activities facilitating changes, modifications to projects and resolution of project problems.
- Evaluates project related supply requests and obtains appropriate approvals for items to include, but not limited to; laboratory/research equipment/supplies, office supplies, and other operational supplies.
- Drafts subcontract modification packages reviews and tracks subcontractor and vendor invoices, tracks subcontract/vendor deliverable submissions, and issues blanket releases.
- Supports Clinical Trial Agreements (CTA) by reviewing, preparing and tracking monthly milestone/site payment reports, reviews and tracks CTA invoices.
- Coordinates translation services and reviews translated study related documents.
- Responsible for monitoring and tracking specimen shipments and reviewing shipment invoices.
- Develops and assists maintaining comprehensive project specific databases, trackers and metrics using various tracking systems such as Microsoft Excel, SharePoint, Smartsheet and other applicable project and program related software.
- Contributes to the establishment and implementation of systems for project reporting including preparation of reports and other project report requirements.
- May coordinate logistical needs for in person and virtual meetings including scheduling meeting invites, drafting agendas, meeting notes, taking and tracking action items, storage and distribution of meeting materials.
- Composes and edits various program and technical communications and documents, including spreadsheets, standard processes, standard operating procedures, presentations and other communications.
- Performs assignments independently with guidance and direction, as appropriate.
- This position is located in Frederick, Maryland.
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 or four (4) years related experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
- No additional experience is required in addition to the education requirements.
- Excellent public speaking, writing, and interpersonal communication skills.
- Ability to work in a fast-paced clinical research setting both independently and within a team.
- Strong organizational skills with the ability to prioritize multiple tasks/projects.
- Proficiency with Microsoft Project (Word, Excel, Outlook, PowerPoint).
- Ability to obtain and maintain a security clearance.
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Knowledge of Smartsheet, SharePoint and other project tracking software.
- Experience in report writing and metrics tracking.
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork