The Contractor -TMF Manager/Veeva Specialist will provide support to the Clinical study team for the conduct of Clinical Trials according to ICH-GCP and local and international applicable regulations. This hybrid position is accountable for the implementation, management, and maintaining control of record management processes related to the electronic Trial Master File (eTMF), CTMS, able to work on configurations and integrations within the system. Ensure compliance with internal policies as well as external regulations.
Duties & Responsibilities:
TMF Responsibilities
Manages document control processes and systems for GCP activities in compliance with internal procedures and policies as well as regulatory requirements:
Maintains the eTMF records management system including secure storage, retrieval, retention, and destruction per SOPs
Manages the day-to-day routing, review (including for accuracy and completeness), approval, distribution, and archival of clinical documents in accordance with the SOPs and ICH GCP, ensures compliance with relevant legislation and regulations
Manages TMF Record integrity
Performs TMF completeness quality check (QC) review, provides findings to the clinical team and provides support to the team to ensure compliance is maintained
Performs pre-Audit/Inspection review of TMF (Trial Master File) and ISF (Investigator Site File) documentation in accordance with SOPs
Provides TMF business guidance to study teams, functional areas, and document users.
Support Shionogi in process of developing a global Shionogi TMF structure.
Support and oversee the TMF migration process from CRO eTMF system to Shionogi eTMF system (Veeva Vault) for Record Management/business group.
Works to ensure successful eTMF systems global implementation.
Organize and attend the study team meetings to discuss the TMF status of each study and provide resolutions to any TMF maintenance and management-related questions from the study team.
Serve as a core team member in the revision and update of Shionogis TMF related SOPs, WIs, and plans.
In collaboration with the Clinical Trial Manager, ensures high-quality TMF set-up and management (onboarding of study contributors, completion of the TMF management plan, study-specific preparation of documents in the system, periodic reviews, etc.)
Organize and provide TMF/eTMF process implementation training to all study teams and cross-functional areas involved in TMF filing, to ensure Shionogis inspection readiness and TMF compliance with GCP guidelines, regulatory requirements, and SOPs and policies.
Ensures TMF record management documents and processes are periodically reviewed for relevance to ensure actual practices are reflected as defined in applicable procedures and are in compliance with regulatory requirements
Provides support to clinical teams during regulatory inspections for record organization and retrieval
Prepares regular metrics and status reports on Document Control for Clinical Trial Management review
Supports study teams in TMF documentation, archiving, and filing
Follows up on open record management queries and ensures their full resolution
organizing and providing TMF process implementation and training as per company policies and regulatory requirements to study teams and functional areas involved in TMF filing and review
ensures GxP inspection readiness for Clinical Study TMF documentation and records for inspection by internal or regulatory agencies.
provides TMF business process guidance ensuring that project documentation is maintained to the highest level of quality, completeness, and compliance while aligning with the company and departmental objectives.
System Responsibilities
Able to work in Veeva system with technical expertise (trouble shoot reports, support EDLs review, manage process, support periodic checks and completeness review of eTMF and review CTMS reports for completeness
Technical expertise in Veeva system including troubleshooting, configurations, and integration
Minimum Job Requirements
Bachelor's degree or equivalent education in record management, life sciences, or related fields
5 years of relevant experience within the Pharmaceutical industry/ Clinical Research
Excellent knowledge of ICH-GCP guidelines and FDA/EMA/PMDA regulations
Excellent working knowledge of clinical study documentation
Experience with eCTM and TMF software preferably Veeva.
Ability to understand technical, scientific, and medical information
Understanding of drug development process and concepts of clinical research.
Proficient in MS Office, MS Excel; able to work with databases.
Ability to articulate clearly and conduct verbal presentations with large and small audiences.
Foundational understanding of basic adult learning principles.
Ability to work in fast-paced, data driven environment.
Ability to create a narrative using metrics and KPIs.
Ability to establish, sound working relationships with both internal and external stakeholders.
Hybrid work arrangements will allow work from home combined with your presence on-site at our US HQ in Florham Park, NJ.
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 responsibilitiesmay 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)
Clinical Development
