Clinical Trial Assistant

Location
Brisbane, CA, United States
Posted
Apr 21, 2021
Ref
5216726002
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
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 located at our Brisbane office. The position reports to the Clinical Trial Manager.

Essential Duties and Responsibilities
  • Establishes and maintains the TMF with minimal supervision of the CTM
  • Assists clinical operation leads in the development, handling, distribution, filing and archiving of essential documents in the TMF
  • Assists 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
  • Handles incoming and outgoing clinical trial related materials shipments to site, study team, CRAs and vendors, as needed
  • Assists with all aspects of initial study drug release including regulatory packet review and study-drug release
  • Assists clinical study team with the planning, preparation, and on-site support of investigators meetings.
  • Participates in the EDC and IXRS specification process, as appropriate
  • Communicates 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
  • Assists with tracking of clinical trial progress including status updates reports, as requested
  • Assists with final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopses, protocols and amendments, and other documents, as required
  • Participates in clinical team meetings, may coordinate meetings/teleconferences/Zoom. Prepares agendas, minutes and tracks action items.
  • May be assigned other projects and duties as required

Core Competencies
  • Must be familiar with routine medical/scientific terminology
  • Effective time management and organization skills
  • Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
  • Skilled in developing collaborative internal and external relationships.
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
  • 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

REQUIREMENTS (Education and Experience)
  • BS/ BA in a relevant scientific discipline, RN, or related field is preferred
  • Minimum 0 - 3 years of relevant experience in biotech or pharmaceutical industry

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 careers@myovant.com.

Equal Employment Opportunity