TMF Manager (Finance)

Overview
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.
Responsibilities

• Supports company management with successful eTMF system's global implementation.
• Execute the strategy, management, and integration of an electronic TMF system, including vendors and technology. This will involve hands-on participation in the configuration and maintenance of the eTMF.
• 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
• Leads TMF Team in review and development of TMF SOPs, Guidance Document, TMF training processes.
• Provides training to study teams, including external partners and CRO staff in compliance with SOPs, WIs and regulatory requirements.
• Coordinates TMF documentation collection, review, and submission with stakeholders
• Leads meetings to escalate trends, issues, and establish standards, while problem-solving and seeking appropriate endorsement across study teams and functions. Communicates ideas, solutions, and standards.
• Collaborates with management to develop metrics to assess the completeness and quality of the eTMF and effectively communicate status updates to the study team and department management. Works with external partners and study team to address gaps, issues and mitigate risks.
• Serves as the Subject Matter Expert for TMF during Inspections and audits; collaborates with inspection readiness teams and regulatory authorities on TMF-related inquiries and inspections.
• Conducts periodic TMF reviews ensuring GxP inspection readiness for Clinical Study in accordance with regulations.
• Prepares and shares regular TMF metrics and status reports to study teams and CROs on the allocated studies
• Participates in process improvement efforts by identifying and reporting gaps in processes to company management.
• Manages and tracks TMF-related actions, issues, and risks and provides TMF-related guidance to stakeholders.
• Other duties as assigned.

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

Preferred Skills & Experience

• Ability to collaborate and communicate effectively across geographies and cultures and at all levels.
• Ability to build cross-functional and cross-geographic partnerships and influence without authority.
• Ability to independently and effectively organize tasks to achieve established deadlines.
• Strong written and verbal communications skills.
• Ability to facilitate global team workshops and discussions.
• Proficiency with the Microsoft Office Suite software.
• Experience analyzing relevant databases (e.g., IMS) is a plus.

Additional InformationThe base salary range for this full-time position is $120,000-$150,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, vehicle allowance, bonus, long-term incentive, or any additional compensation that may be associated with this role.
EEO
Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), 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 for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory. If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.