Clinical Project Manager I

Clinical Project Manager I

Job ID: req2882
Employee Type: exempt full-time
Division: Applied & Development Research Program
Facility: Rockville: 9609 MedCtrDr
Location: 9609 Medical Center Dr, Rockville, MD 20850 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 Frederick National Laboratory for Cancer Research (FNL) is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by the prime contractor Leidos Biomedical Research, Inc. FNL is responsible for pursuing a unique mission in translational and applied biomedical research that is unsuitable for academia, the pharmaceutical industry, or other federal contractors.  This position is ideally suited for a person who is interested in clinical trials that incorporate precision oncology principles to accurately match therapeutics to biomarker profiles and investigate possible improvements in clinical outcomes.

KEY ROLES/RESPONSIBILITIES

Assist clinical investigators and NCI medical officers with:

• Planning, execution and operations of clinical trials 
• Monitoring cost, scope, schedule, and efficiency of trials versus requirements
• Integration of cross-functional plans into clinical trials
• Project team meeting scheduling, execution, agenda, minutes, action items, and effectiveness
• Analyze clinical trial activities of multiple contributors and report on their conduct, coordination, and timely completion to senior management at FNL and NCI
• Interact professionally when communicating with clinical investigators, NCI medical officers, clinical assay laboratories and their data submitters, and IT professionals and their clinical trials coordinating center to contribute to investigation and mitigation of root causes of data submission curation problems, to coordinate communication between clinical and laboratory testing groups, and to contribute to patient specimen workflows, tracking, management and accountability
• Identify, propose and facilitate improved workflows and enhanced operational efficiencies of the clinical trials

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). (Additional qualifying experience may be substituted for the required education)

• Foreign degrees will be evaluated for U.S. equivalency
• In addition to education requirements, at least 2 years of relevant experience in oncology clinical trials
• Ability to work in a team environment consisting of clinical and medical laboratory staff to define problems and find corrective actions
• Familiarity with, and understanding of, oncology clinical trials and their operational aspects, including but not limited to records and information that requires management and integration as well as the regulatory and reporting requirements
• Willingness and ability to work in strict compliance with policies & procedures, rules and regulations that govern precision oncology clinical trials
• Demonstrated time management and organizational skills
• Demonstrated excellence in oral and written communication skills
• Demonstrated experience using Microsoft Office applications, including Outlook, Excel, Word, Teams, and Sharepoint
• Strong inter-personal skills
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:  

• Direct experience of 2+ years in, and understanding of, precision oncology clinical trial operations, types of information that needs to be managed and integrated, and regulatory and reporting responsibilities.
• Knowledge and working experience with an Electronic Data Capture system, for example, Medidata’s RAVE Data Management systems
• Knowledge and understanding of HIPAA requirements
• Formal certification, education and/or training in clinical project management, for example, PMP certification

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

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