General Dynamics Information Technology – Federal Civilian Division is looking for a Clinical Trials Manager to join our team to support the Department of Army. This position is based in the Ft. Detrick and Frederick, Maryland.
This position shall provide regulatory support for clinical trial project management, clinical development strategies, execution of clinical trials, and provision of clinical site training. Duties include:
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
Bachelor’s Degree or the equivalent combination of education, professional training, or work experience.
8 years of related experience.
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.
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.