Clinical Trial Manager

GDIT's Military Health team is hiring a Clinical Trial Manager to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army). The position is located in Frederick, Maryland. It is a hybrid role, and you would be required to be on-site 1-2 days/week.The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.

The position is located in Frederick, Maryland. It is a hybrid role, and you would be required to be on-site 1-2 days/week.

RESPONSIBILITIES:

• Manage single site and multicenter clinical studies both inside and outside the continental United States; manage other entities supporting the conduct of clinical trials to ensure all sponsor required trial monitoring is conducted and all deliverables are received, providing updates to leadership and sponsor’s representative through Gantt Charts or other acceptable tracking tool
• Write, review, and/or revise trial specific standard operating procedures or study specific procedures, including standard operating procedures for specific research, pharmacokinetic assays, or other testing not described in the trial procedure manual
• Provide regulatory inspection notifications and any report generated from an inspection or external audit to the sponsor
• Review and revise protocols, informed consent forms, and other study related documents to include the initial versions and amendments. This is including, but not limited to the informed consent, Investigators Brochure, source documents, study procedures manual, study specific procedures, pharmacy manual, FDA Form 1572, clinical trial agreement(s), and transfer of regulatory obligations documentation (FDA Form 1571 listing the obligations transferred).  
• Coordinate, lead, or participate in study working groups, which include protocol development working groups, risk assessment groups, product or manufacturing working groups, and other working groups established by the integrated product team, and write or review the associated minutes
• Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities
• Prepare and/or review sample handling instructions to include volume of the sample, tube or container for collecting the sample, sample collection time points, special instructions for processing and storing samples, instructions on how and where to ship specimens, and documentation requirements for sample accountability, which may be part of Trial Procedure Manuals or stand-alone instruction manuals, standard operating procedures, or study specific procedures
• Develop study specific grading criteria, and use them to conduct viability assessments during site qualification visits to document whether or not a proposed clinical site and principal investigator meet the requirements for execution of the proposed clinical trial
• Assist in investigator selection, which includes documenting the qualifications and experience of the investigator with, at a minimum, the curriculum vitae, current Good Clinical Practices and Human Subjects Protection training certificates, and the medical license (if applicable)
• Assist in monitor selection, which includes documenting the monitor’s qualifications and experience

​REQUIRED QUALIFICATIONS

• Bachelor’s Degree or the equivalent combination of education, professional training, or work experience.
• 8 years of related experience within clinical research, managing clinical trials
• Must be highly organized, detail oriented, and perform independently. 
• Have excellent Microsoft Excel Spreadsheet skills.
• Excellent written and oral communication skills.
• Must be U.S. citizen and be able to obtain a TI (Public Trust).
• Some travel may be required.
• The position is located in Frederick, Maryland. It is a hybrid role, and you would be required to be on-site 1-2 days/week

WHAT GDIT CAN OFFER YOU: 

• Challenging work that makes a real impact on the world around you  
• Internal mobility team dedicated to helping you own your career 
• 401K with company match 
• Diverse, highly collaborative teams
• Professional development, education assistance, certification and training opportunities

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