Clinical Project Manager II, Project Management
- Employer
- Frederick National Laboratory for Cancer Research
- Location
- Frederick, MD, USA
- Start date
- Sep 12, 2020
View more
- Discipline
- Clinical, Clinical Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
Job Details
The Clinical Monitoring Research Program Directorate (CMRPD) provides specialized support for initiatives and special projects in support of the National Institute of Allergy and Infectious Diseases (NIAID) Division of Clinical Research (DCR). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging infectious disease studies globally. All or a portion of these research studies will be coordinated through a Clinical Research Organization (CRO).
KEY ROLES/RESPONSIBILITIES
Responsibilities include but are not limited to:
- Provides collaborative leadership and management oversight and coordination of research projects and other initiatives
- Performs a significant level of project/program management activities including utilizing project/program management tools and techniques to organize, plan, execute, report, and evaluate program objectives
- Works independently with minimal direction and often provides direction to others
- Participates in the execution of projects and provides technical guidance in the development of administrative and operational processes, templates, procedure manuals, and other documents
- Provides support to the development and implementation of various operational plans and technical/logistical tracking systems to meet research and operational needs
- Monitors progress against plans and key deliverables
- Manages project risk by proactively anticipating issues and develops contingency plans and solutions
- Provides assistance to clinical research teams in the development of protocol specific plans that adhere to the International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), the National Institutes of Health (NIH) Standards of Clinical Research, U.S. and international regulations
- Interacts with auditing and monitoring agencies to facilitate the exchange of information
- Maintains coordination and communication between research operations, program management, project stakeholders and team members, and acts as liaison between government customers and subcontractors on behalf of CMRPD
- Is responsible for various subcontract planning, development and implementation activities, including preparing statements of work, evaluating proposals including pricing, monitoring budgets, and serving as the technical representative for subcontract management oversight for assigned activities
- Develops payment models for clinical trials sites
- Provides input into Leidos Biomed reporting deliverables
- Oversees and monitors the technical work of subcontractors, and performs review and verification of subcontractor deliverables and invoices
- Performs a high degree of knowledge transfer related to project/program management concepts and practices and provides guidance and coaching to team members
- Supervises multiple levels of staff
- Conducts team meetings and assists in the development of meeting agendas
- Prepares and reviews progress reports
- Position may travel 10-20% domestically and internationally
- This position is located in Frederick, Maryland
BASIC QUALIFICATIONS
- 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 three (3) years directly managing multiple concurrent clinical projects
- Extensive experience in contract management and reporting
- Previous project management and/or study coordination experience including data management and research subcontracting
- Experience related to clinical operations (e.g., development of Standard Operating Procedures [SOPs], staff development and training, resourcing/staffing, and budget planning and execution)
- Must be able to obtain and maintain a clearance
PREFERRED QUALIFICATIONS
- Clinical Research or Project Management Professional with infectious disease experience
- Knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
- Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
- Familiarity with the management 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
- Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
- 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
- Ability to travel internationally
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork
Company
A rewarding career with global impact
Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.
Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.
We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.
Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.
Discover why joining the Frederick National Laboratory team could be the most important career step you take
- Website
- https://frederick.cancer.gov/
- Phone
- 301-846-1000
- Location
-
8560 Progress Drive
Frederick
MD
21701
US
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