Overview
The TMF Contractor 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.
Responsibilities
Below is a list of the main activities needed to fulfill the requirements of the assignment. It is not meant to be comprehensive but rather provide an overview of the specialized skills and expertise required:
Ensures the TMF project documentation is maintained to the highest level of quality, accuracy, completeness, and compliance with regulations
Manages document control processes and systems for GCP activities in compliance with regulatory requirements
Implements/Maintains TMF quality control processes aligned to company standards and within regulatory requirements
Organizes and provides TMF process implementation training to study teams ensuring compliance with SOPs, WIs and regulatory requirements
Coordinates TMF documentation collection, review, and submission with stakeholders
Manages and tracks TMF-related actions, issues, and risks and provides TMF-related guidance to stakeholders
Prepares and shares regular TMF metrics and status reports to study teams and CROs on the allocated studies
Conducts periodic TMF reviews ensuring GxP inspection readiness for Clinical Study in accordance with regulations.
Collaborates with inspection readiness teams and regulatory authorities on TMF-related inquiries and inspections.
Supports company management with successful eTMF system's global implementation.
Participates in process improvement efforts by identifying and reporting gaps in processes to company management.

Minimum Job Requirements
Bachelor's degree or equivalent education in life sciences, record management, public health management, or related fields
5 years relevant experience within the pharmaceutical or biopharmaceutical industry
Knowledge of international and local regulatory requirements for clinical trials and guidelines, such as ICH-GCP and FDA/EMA/PMDA regulations
Understanding of clinical trial processes, including study design, patient recruitment, data management, and reporting
Experience with electronic TMF systems and technologies, preferably Veeva Vault and with other technologies such as MS Office applications and databases
Experience in managing multiple projects and coordinating with cross-functional teams
Ability to prioritize, manage, organize, and maintain large amounts of documentation, both electronic and paper
Effective communication and interpersonal skills
Ability to learn new concepts with reasonable ease and train others on new concepts in a manner that is easily understood and comprehended
High attention to detail to ensure that all required documentation is accurate, complete, and compliant
Ability to identify and manage risks and resolve issues in a timely manner
Skilled at problem-solving and proposing solutions

DISCLAIMER 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. You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.
EEO
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.


Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity