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 Development & Regulatory Affairs 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
- 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
- Some travel would be required for site selection and training, monitoring responsibilities
- 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 Type: Full-time, office-based (except during Covid or other situations requiring remote work), salary, benefits, stock options, bonuses.