Req ID: RQ207934
Type of Requisition: Regular
Clearance Level Must Be Able to Obtain: None
Public Trust/Other Required: NACLC (T3)
Job Family: Ancillary Health
Skills:
Clinical Research,Clinical Trials,Standard Operating Procedure (SOP)
Experience:
5 + years of related experience
US Citizenship Required:
Yes
Job Description:
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 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 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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The likely salary range for this position is $66,300 - $89,700. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
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Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
