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 develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Manager, Trial Master File Operations. The position reports to the Director, Operational Excellence. The location of the position is in Brisbane, CA.
The Manager, Trial Master File Operations is responsible for developing and implementing processes, systems, and training programs related to clinical trial documentation to ensure GCP compliance and inspection readiness within Clinical Development. The TMF Operations Manager provides expertise related to the TMF, including essential documents (EDs) and eTMF systems, and other clinical trial processes. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties and Responsibilities
- Function as the Clinical Operations TMF process owner by providing expertise and best practices related to clinical documentation, including EDs, TMF processes, and eTMF systems
- Define and lead the creation, deployment, and management of key TMF processes, including development of associated Standard Operations Procedures (SOPs), training, and tools to ensure GCP compliance and inspection readiness
- Build and maintain strong partnerships cross functionally to ensure TMF completeness
- Assists study teams with the TMF, including initiation of the TMF through archival, as needed as well as the transfer of TMF documents from vendors
- Performs routine quality assessment of Myovant’s and/or vendor’s TMF and/or key TMF essential documents on an ongoing basis
- Lead appropriate Clinical Development document related Regulatory Inspection Readiness activity
- Leads and/or participates in projects developing and implementing key clinical systems, such as eTMF
- Attends and participates in required meetings. May coordinate meetings/ teleconferences/WebEx’s. Prepares agendas and minutes and tracks action items as needed
- May be assigned to other projects and duties as required
Core Competencies, Knowledge, and Skill Requirements
- Advanced knowledge of FDA/EU and ICH – GCP regulations and guidelines
- Knowledge of clinical and regulatory documentation requirements
- Advanced knowledge and experience with Word, PowerPoint and Excel
- Continuous improvement mindset and the ability to work independently with a proactive, self-starter attitude
- Detail-oriented with a commitment to accuracy
- Ability to multi-task and shift priorities quickly while working under tight deadlines
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Demonstrates a positive, ‘can do’ and service-oriented attitude
- Excellent verbal and written communication skills
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company
- Strong interpersonal skills with the ability to work with cross functional teams
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline is preferred
- 5-8 years of experience in the pharmaceutical, biotechnology, CRO and/or health care setting
- Minimum of 3 years records or document management experience in a GCP regulated environment
- Experience with electronic document management systems, experience with Veeva preferred
- Experience supporting regulatory submissions and inspections preferred
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Close vision required for computer usage
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.
Equal Employment Opportunity