Clinical Trial Management Associate
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 Management Associate located at our Brisbane office.
The position reports to a Clinical Trial Manager (CTM), Sr CTM or Operations Portfolio Lead (OPL), and is responsible for supporting the operational execution, oversight and management of one or more clinical trials from start-up through close-out. The individual provides assistance in ensuring the quality oversight of CROs and other clinical service providers (CSPs).
Essential Duties & Responsibilities
- Assist in protocol execution and all operational aspects on one or more clinical trials from start-up through close-out while following SOPs and ensuring compliance with country regulations and ICH/GCP guidelines
- Assist in CRO interactions, including implementation of operational functional activities (e.g., study management, site monitoring, site management, etc.)
- Assist in the development of internal and external study documents/plans including, but not limited to, clinical monitoring and management, Team Charter, TMF management, protocol deviation, Screening/Enrollment closure, pharmacy manual, etc.
- Review site-level study documents (e.g., informed consent forms, study tools/worksheets, etc.)
- Review essential documents for accuracy and compliance to Standard Operating Procedures (SOPs), ICH/GCP, and applicable regulatory requirements as needed
- Assist with the preparation of key study documents including protocols, ICFs, CRFs, Clinical Study Reports (CSR), NDA submission, as appropriate
- Assist in preparing study status metrics and risk mitigations for senior management, as assigned
- Assist in clinical data review for assigned clinical trial(s)
- Actively participate in activities, as assigned, to maintain inspection readiness at all times on clinical trial(s)
- Assist with generating study related slides and organizing and presenting at internal team meetings, investigator meetings, site trainings, and other trial-specific meetings
- Participate in the EDC and IXRS specification process, as appropriate
- Manage and file documents within the Trial Master File (TMF), including conducting periodic reviews of TMF records maintained by Myovant and/or Contract Service Providers (CSPs)
- May perform some or all of the duties and responsibilities outlined for a Sr Clinical Trial Assistant, as needed
- Identify and escalate issues appropriately
- May be assigned other projects and duties as required
- Demonstrate communication, collaboration and organizational 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
- Able to work in a strong team-oriented environment and effectively develop collaborative internal and external relationships
- Detail-oriented without losing sight of the big picture.
- Possess project management skills with ability to manage multiple projects, complex timelines and shift priorities quickly while working under tight deadlines in a team environment
- Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials
- Must have knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
- Demonstrated proficiency in MS Office (Outlook, Word, PowerPoint and Excel) and experience with Smartsheets is a plus
- May require occasional domestic and international travel
REQUIREMENTS (Education and Experience)
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline
- At least 3 - 4 years of clinical trial experience
- Prior experience as a study coordinator or Clinical Trial Assistant preferred
- Experience working within a small biotech company preferred
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