The Trial Master File Operations Manager provides support to the Director of Systems, Solutions and Processes in the development and implementation of processes, systems, and training programs to ensure GCP compliance and inspection readiness within Clinical Operations.  The Trial Master File 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

  • Provides expertise and best practices related to the TMF, including EDs, TMF processes and eTMF systems, and other clinical trial processes
  • Supports the Director of Systems, Solutions and Processes with development and implementation of Clinical Operations processes, including development of training materials and tools associated with the process
  • Provides expertise and participates in projects developing and implementing key clinical systems, such as eTMF
  • Assists clinical 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 Contract Research Organization’s (CRO’s) TMF and/or key TMF essential documents as needed
  • Identifies and escalates clinical trial process gaps or inconsistencies across Myovant programs and risks to clinical trial execution success
  • Attends and participates in required meetings. May coordinate meetings/ teleconferences/WebEx’s. Prepares agendas and minutes and tracks action items as needed
  • Identifies and escalates issues appropriately
  • 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
  • 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

 

REQUIREMENTS

Education 

  • BS/BA in a relevant scientific discipline, RN, or related field is preferred

 

Experience

  • 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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