Clinical Project Manager II

Job ID: req2992
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 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

The Clinical Research Directorate (CRD) Drug Discovery and Development Program provides project and operational management of initiatives in support of the National Center for Advancing Translational Sciences (NCATS). NCATS supported efforts include management of the TRND (Therapeutics for Rare and Neglected Diseases) and BrIDGs (Bridging Interventional Development Gaps) drug development programs. TRND and BrIDGs stimulate drug discovery and development collaboration between NIH, Leidos, academic scientists, nonprofit organizations, and pharmaceutical and biotechnology companies. TRND focuses on rare and neglected illnesses, while BrIDGs accepts applications for any worthy project.

KEY ROLES/RESPONSIBILITIES

• 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
• 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
• Conducts team meetings and assists in the development of meeting agendas
• Prepares and reviews progress reports
• 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 or university (according to CHEA) in a field related to biomedical/biochemical research. Foreign degrees will be evaluated for U.S. equivalency.
• A minimum of eight (8) years related biomedical/biochemical experience.
• Ability to demonstrate increased independence and overall responsibility for more complex projects at a program/directorate level
• In depth working knowledge of drug development or clinical trial fieldwork concepts and practices with specific knowledge of development and monitoring requirements
• Ability to manage drug development and research projects, both independently and within a team
• Ability to critique and evaluate scientific reports relative to drug development or clinical trials
• Knowledge of federal regulations governing drug development and/or clinical research, including International
• Conference on Harmonization (ICH) and Good Clinical Practice (GCP) requirements
• Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks/projects
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff including senior level management and officials
• Ability to effectively manage staff and render decisions and policy interpretations
• Effective negotiation skills and ability to manage budgets and procurement
• Knowledge of the principals of budgeting, contracting, engineering, legal, clinical and/or laboratory procedures, space management, laboratory renovations, and technical writing
• Ability to obtain and maintain a security clearance
  

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Logistical experience
• Possession of a Ph.D. degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) (Additional qualifying experience may be substituted for the required education)
• Eight (8) years of progressively responsible, relevant experience in clinical research, including three (3) years directly managing multiple concurrent development or clinical projects

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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