Clinical Operations, Manager, Trial Master File Operations
Myovant Sciences is a biopharmaceutical startup company focused on delivering innovative women’s health and prostate cancer solutions. We are currently seeking a qualified, highly motivated, experienced individual for the position of Clinical Operations, Manager Trial Master File (TMF) Operations. The position reports to the Director of Systems, Solutions and Processes within Clinical Operations. The location of the position is in Brisbane, CA.
The Clinical Operations TMF Operations Manager reports to the Director of Systems, Solutions and Processes and is responsible for developing and implementing processes, systems, and training programs to ensure GCP compliance and inspection readiness within Clinical Operations. The TMF Operations Manager also 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 & Responsibilities
- Acts as the Clinical Operations TMF process owner by providing expertise and best practices related to the TMF, including EDs, TMF processes, and eTMF systems
- Leads the creation, deployment, and management of key TMF processes, including development of associated Standard Operations Procedures (SOPs), training, and tools
- Leads and/or participates in projects developing and implementing key clinical systems, such as eTMF
- Assists study teams with the TMF, including initiation of the TMF through archival, as needed as well as the transfer of TMF documents or the TMF from vendors
- Performs routine assessment of Myovant’s and/or vendor’s TMF and/or key TMF essential documents as needed
- Leads the creation, deployment, and management of other Clinical Operations’ processes to ensure GCP compliance and inspection readiness, including development and maintenance of associated SOPs, training, and tools
- 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
- Must be familiar with FDA/EU and ICH – GCP regulations and guidelines
- Working knowledge and experience with Word, PowerPoint and Excel
- Ability to work independently and with a team
- Effective time management and organization skills
- Detail-oriented with a commitment to accuracy
- Ability to multi-task and shift priorities quickly while working under tight deadlines
- Good interpersonal, written and verbal communication skills
- Skilled in developing collaborative internal and external relationships
- 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
- Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks
Communication & Interpersonal Skills
- 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
- BS/BA in a relevant scientific discipline, RN, or related field is preferred
- 5-8 years of experience in the pharmaceutical, biotechnology, CRO and/or health care setting
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.
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Equal Employment Opportunity