Top Reasons to Work at AGT

Your work would have the potential to transform millions of lives
You‘d be part of something bigger than youself and join a mission to develop genetic medicines to cure and rid the human body of diseases
You would be part of the AGT family, made up of smart, committed, and caring individuals
You would have the opportunity to reach your full potential and apply your knowledge creatively
You would have benefits, includung health insurance, retirement, gym membership, and the potential to own stock in the company

Clinical Study Manager

Clinical Study Manager – Gene and cell Therapy

American Gene Technologies is a leader in cell and gene therapy of infectious diseases, monogenic diseases, and cancer. Located in Rockville, Maryland, we are expanding the capacity for Research and Development of novel therapies and are seeking a Clinical Study Manager for our Clinical Operation team.

The Clinical Study Manager (CSM) is responsible for managing clinical trials from initiation to completion of study protocols, development of case report forms and clinical reports, as well as overseeing site monitoring visits and interfacing with site staff, Clinical Research Organizations (CRO), and other company representatives. The CSM will also independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol. This position is responsible for supporting clinical trials as required.

Duties and Responsibilities include the following:

  • Support the initiation and execution of clinical trials
  • Accountable for all activities of site related study execution of assigned studies involving start-up, execution, and close-out
  • Accountable for the on-time and within-budget study execution of assigned projects, including but not limiting to country and site feasibility.
  • Manage investigational sites and clinical trial vendors such as CROs and external laboratories
  • Prepares clinical study documentation including case report forms, informed consent forms, monitoring plans, and other study-specific plans for sound and thorough data to support the approval process and study objective
  • Ensure monitoring is sufficient such that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements and fulfills the study objective
  • Conducts training regarding the operational aspects of the clinical trial including protocol, lab manuals, etc. to both internal team members and clinical site staff
  • Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols
  • Ensures accurate, timely, and complete tracking of laboratory samples
  • Assist in managing and tracking investigational product
  • Review monitoring trip reports and track resolution of all action items
  • Performs monitoring duties at the site as needed
  • Manage and prepare the clinical documents to support regulatory submissions
  • Support the development of and provide period quality control and review of the Trial Master File
  • Perform other clinical duties when requested

Skill, Knowledge and Abilities Required: 

    • Bachelor’s degree in health profession and/or science field
    • A minimum of five (5) years of clinical affairs experience in the pharmaceutical and/or biotechnology industry
    • Strong knowledge of ICH/GCP and FDA regulations
    • Previous experience leading a clinical study strongly preferred
    • Excellent written and oral communication skills
    • Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
    • Excellent organizational skills and attention to detail
    • Ability to manage projects and resources
    • Able to proactively identify project challenges/risks and implement appropriate actions with some supervision
    • Ability to multi-task and work effectively in a team or independently with a focus on meeting deadlines
    • Ability to travel approximately 15% depending on study status
    • Infectious Diseases experience preferred
    • Cell and Gene Therapy experience preferred


American Gene Technologies (AGT) is an equal opportunity employer and will consider applications without discriminating on the basis of disability, sex or sexual orientation, race or ethnic origin, marital or civil partnership status, or any other characteristic protected by law. AGT employees receive competitive salaries, comprehensive healthcare coverage, paid gym membership, 401K plan with employer contribution, incentive stock options and annual paid leave.

Job Types: Full-time, salary, benefits, stock options.

Pay: $90,000.00 – $95,000.00 per year


  • 401(k)
  • Dental insurance
  • Disability insurance
  • Flexible spending account
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance


  • 8-hour shift
  • Monday to Friday


  • Bachelor’s (Preferred)

Work Location:

  • One location

Work Remotely:

  • No

Applying for the position

We post all of our positions on our website and on Indeed.  If you happen to have an Indeed profile and would like to apply for this open position you can do so by clicking on the button below.  If you don't have an Indeed profile and would still like to apply you may do so by filling out the form below.  Resumes will be reviewed in the order they were received regardless of the method used to apply.