CTRO Operations Director
- Employer
- Frederick National Laboratory for Cancer Research
- Location
- Rockville, MD, USA
- Start date
- May 18, 2019
View more
- Discipline
- Manufacturing & Production, Operations
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
Job Details
KEY ROLES/RESPONSIBILITIES
The Clinical Monitoring Research Program Directorate (CMRPD)/Clinical Trials Reporting Office (CTRO) supports the NCI's Clinical Trials Reporting Program (CTRP), which maintains a comprehensive database of information on all NCI-supported interventional clinical trials open to accrual as of January 1, 2009. This database, also referred to as CTRP, helps identify gaps and duplicate studies in clinical research, facilitates clinical trial prioritization, and standardizes trial data capture and sharing.
- Serves as the lead for the staff comprising the CTRO, including Leidos Biomed and subcontractor staff
- Serves as technical project manager for subcontract utilized to support staffing
- Oversees hiring process and participates in new employee orientation activities
- Supervises/manages staff; ensures team engagement of the CTRO staff/subcontractors
- Facilitates productive engagement and collaboration with CTRP stakeholders
- Stakeholders management, including assisting with managing the needs of the project stakeholders and updating the stakeholders on project status (technical, schedule and financial status)
- Manages the communication between the CTRO and project stakeholders, including defining how members of the CTRO will communicate and optimizing their interaction with other CTRP stakeholders, documenting and distributing project communications and contributing to the development and maintenance of the CTRP communication plan
- Develops and maintains the project schedule, creates a schedule baseline and estimates and monitors project tasks, deliverables, and milestones
- Resource management, including assigning and procuring resources for the project, as required, and monitoring availability and changes in resources and impact on project
- Issue management, including the development and maintenance of a project issues log, managing emergent issues and assignment of issues to resources
- Project quality management, including maintaining project quality standards, monitoring project quality and developing and implementing project quality controls
- Risk management, including analysis and assessment of risk with a project dependencies risk matrix and contingency planning
- Scope management, including developing the project scope in coordination with project stakeholders, monitoring project for scope variances and adjusting scope as required, monitoring deliverables
- This position is located in Rockville, Maryland
BASIC QUALIFICATIONS
- Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation in a related scientific or clinical field (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
- Must be able to obtain and maintain a security clearance
- Experience managing technical teams
- Experience working in support of government contracted work
PREFERRED QUALIFICATIONS
- Demonstrated clinical experience and/or in-depth knowledge of clinical trials, especially in the field of oncology
- Experience working for/collaborating with an NCI-designated Cancer Center or affiliate
- Understanding of clinical trial search interfaces and patient trial matching
- Knowledge of Cancer Center Support Grant process and Data Table 4 requirements
- Understanding of clinical trials reporting requirements and Food and Drug Administration Amendments Act (FDAAA) of 2007
- Experience with automated data systems/web sites that track clinical trials data
- Experience with issue tracking and process documentation
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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