Clinical Trial Assistant (CTA)
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and enthusiastic individuals who share our excitement for this mission.Summary Description
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Clinical Trial Assistant (CTA) located at our Brisbane office. The position reports to the Clinical Trial Manager (CTM) or Senior CTM within Clinical Operations and is responsible for maintaining Trial Master File (TMF) in an inspection-ready state, assisting with site management, initiating collection, reviewing and tracking of essential documents throughout the life of the trial. The individual also contributes to the development, tracking and distribution of study materials and site/study communications.
Essential Duties and Responsibilities
- Assist Clinical Operation leads in the development, handling, distribution, filing and archiving of essential documents in the TMF
- Assist and/or contributes to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans, study communications and presentations
- Handle incoming and outgoing clinical trial related materials shipments to site, study team, CRAs and clinical service providers (CSPs), as needed
- Assists with all aspects of collection and review of site documents including 1572s, CVs, and financial disclosure documents of regulatory packets for initial study drug release to sites
- Assist clinical study team with the planning, preparation, and on-site support of
- investigators meetings
- Communicate directly with sites, Contract Research Organizations (CROs) and CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities
- Assist with tracking of clinical trial progress including status updates reports, as requested
- Assist with final sign off of project and study-related documents including: informed consent forms, monitoring plans, TMF management plans, synopses, protocols and amendments, and other documents, as required
- Coordinate and participate in team meetings/teleconferences/Zoom including preparation of agendas, minutes and tracking action items
- May be assigned other projects and duties as required
- Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
- Exercise good judgment and make decision that is appropriate for the organization
- Results-driven, take initiative and ownership to accomplish work
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
- Self-motivated, with initiative and able to take ownership of, and follow through with, specific tasks
- Demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint) and experience with SmartSheets is a plus
- Required skill in the operation of standard office equipment including: copy machines/scanners and other equipment as necessary
REQUIREMENTS (Education and Experience)
- BS/ BA in a relevant scientific discipline, RN, or related field is preferred
- Minimum 0 - 1 years of relevant experience in biotech or pharmaceutical industry
The well-being and safety of our employees is our top priority. Myovant Sciences requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based). Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
If you require any accommodations, please email firstname.lastname@example.org.
Equal Employment Opportunity