Trial Master File (TMF) Manager (Legal)
The Trial Master File (TMF) Manager will provide specialized skills and expertise in support of our clinical trials and be responsible for overseeing and managing the Trial Master File for designated clinical trials, provide training to stakeholders, and be responsible for capturing key metrics and the presentation of such with stakeholders. Additionally, will provide TMF expertise during audit-readiness and audit day for designated studies.
This role is accountable for implementation, management, and maintaining control of Trial Master File (TMF) processes related to the electronic Trial Master File (eTMF) in compliance with internal policies as well as external regulations.
PREFERRED SKILLS AND EXPERIENCE
ESSENTIAL PHYSICAL AND MENTAL REQUIREMENTS
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
“Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.”
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.