Trial Master File

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.

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 AND 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.

ESSENTIAL PHYSICAL AND MENTAL REQUIREMENTS

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

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.”

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.

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.