Clinical Project Manager III - REMOTE

Clinical Project Manager III - REMOTE

Job ID: req3739
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: 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.

***THIS POSITION IS CONTINGENT ON FUNDING APPROVAL.

PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides strategic, operational, and program/project management support to domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and various other institutes within the National Institutes of Health (NIH). CMRPD’s services are strategically aligned with the mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD manages research initiatives and supports clinical trials that investigate the prevention, diagnosis, and therapeutic treatment of cancer, influenza, HIV, and other diseases and disorders.  

CMRPD manages a broad range of clinical research projects and provides administrative support services in response to the scientific directions and priorities of NIAID’s Division of Intramural Research (DIR) and NCI’s intramural and extramural initiatives.  CMRPD’s services exist to meet the expanding and emerging challenges faced by NIH researchers. The program’s flexibility, agility, and adaptability amid evolving situations accelerate the scientific advancement of scientific discoveries for human health by supporting rapid-response clinical research initiatives for NCI and NIAID. Specifically, CMRPD is providing project and operational management to support NIAID DIR’s flavivirus vaccine clinical development for effective prevention and treatment means of various mosquito-borne viruses such as dengue and Zika, using controlled human infection models to evaluate the protective efficacy of candidate vaccines. This work involves management oversight of a clinical evaluation subcontractor.  Additionally, CMRPD’s management oversight activities ensure stakeholder engagement, cross-functional collaboration, and the ability to support high-quality clinical research that complies with applicable regulations and guidelines. 

This position is flexible and can be 100% remote work, on-site in Frederick, MD, or hybrid. Candidates from across the U.S. are encouraged to apply. 

KEY ROLES/RESPONSIBILITIES

Responsibilities include but are not limited to:

• Provides clinical operations leadership for domestic and international clinical trials and special projects
• Works closely with program and project leadership to implement the clinical trials, including developing overarching project plans with scope and timelines
• Responsible for various subcontract planning, development, and implementation activities, including preparing statements of work and evaluating proposals
• Oversees and monitors the technical work of subcontractors and performs review and verification of subcontractor deliverables and invoices
• Sets expectations for operational performance of subcontractors
• Provides oversight and technical expertise in the implementation and execution of the clinical studies
• Anticipates obstacles and implement solutions
• Designs and writes request for proposals, portions of abstracts, presentations, and manuscripts, participates in the development of SOPs, INDs, Clinical Study Reports and other clinical, regulatory and safety documents
• Ensures appropriate communication plans are in place to facilitate and maintain communication among scientific, regulatory, safety, monitoring, laboratory, and subcontract project team members
• Leads interactions with CROs and other vendors as well as with domestic and international site staff
• Manages budget development, cost estimating and forecasting
• Reviews and recommends resource changes based on identified gaps and evolving project needs
• Monitors study accrual and assists to identify strategies to increase enrollment
• Collates, reviews, and analyzes metrics to ensure key clinical trial project timelines are met, and identifies trends and opportunities for improvement
• Provides input and acts as part of the team that manages/monitors ancillary activities such as protocol development/amendment, manual of operations development, data management processes including Case Report Form (CRF) development, biospecimen management, laboratory kit design, and study supply management including ordering, tracking and labeling
• Maintains extensive knowledge and understanding of international and domestic clinical research regulations and compliance requirements
• Provides guidance on clinical protocol requirements and reviews and/or develops operational processes, procedures, and documents required to manage projects effectively, including study planning, start up, implementation and close out
• Provides input for training materials for delivery to research staff and study teams on conference calls and in-person at investigator meetings
• Performs a high degree of knowledge transfer related to project/program management concepts and practices and provides guidance and coaching to team members and new hires
• Supervises staff with a diverse range of expertise to include, administrative, project management, business operations, clinical research operations and trial management
• May supervise other operational project staff, and may be asked to perform other related duties as assigned by a responsible manager 

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 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 education requirements, a minimum of ten (10) years of progressively responsible relevant experience in the clinical operational support of multi-center international and domestic clinical trials, including a minimum of six (6) years directly managing multiple concurrent clinical projects
• Ability to manage large cross-functional study teams and external collaborators
• Experience overseeing the work of subcontract CROs and vendors
• Excellent written and oral communication skills including strong report writing and presentation skills
• Strong interpersonal and cross-cultural communication skills
• Knowledge and understanding of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, regulatory, ethics and other requirements for domestic and international studies
• Expertise in analysis, planning, and problem solving
• Strong organizational skills with the ability to prioritize and manage multiple tasks with a high degree of accuracy and attention to detail
• Ability to work effectively both independently and as a team member with consistent ability to take initiative and make an active contribution to the team's performance
• Demonstrated proficiency in Windows® and Microsoft® Office Suite including Word®, Excel®, and Outlook®
• Position may travel 5-10% domestically and internationally 
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Master's degree
• Clinical Research or Project Management Professional with oncology and/or infectious disease experience
• Familiarity with the management of study products and supplies
• Familiarity with Federal Acquisition Regulations (FAR)
• Experience conducting federally funded research studies
• Knowledge of Microsoft Project or other project tracking software
• Ability to work diplomatically with regulatory agencies within complex international environments
• Demonstrated success in previous positions in deployment and implementation processes

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.

#readytowork