Senior Manager, eTMF System

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.  If this is your profile, we want to hear from you.

The Sr. Manager is to lead collaboration efforts with RandD IT to implement and maintain  Eisai’s global (Veeva) eTMF system. To provide oversight and guidance to ensure the eTMF system aligns with Eisai TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements.  This role also provides direction, leadership and training on the eTMF to ensure users are effectively utilizing the eTMF system for active and archived studies.  This includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.  The Eisai eTMF system has global users, including contract research organizations (CROs) which requires individual and appropriate access rights oversight.

The Sr. Manager will be required to work collaboratively with group members and contribute to positive team relationships, both locally and globally.  This role will identify, lead and participate in TMF system and process improvement initiatives, including SOP reviews, TMF reporting and serve as a subject matter expert in TMF Management.

Will include but will not be limited to the following activities:

• Provide oversight to eTMF system administration activities (i.e. study set-up, country/site updates, user access, etc.)

• Triage and assess eTMF system related issues and collaborate with relevant stakeholders (i.e. R&D IT, eTMF vendor) to identified innovative solutions, resolve and/or escalate as needed.

• Provides strategic oversight of eTMF System Management team and eTMF vendors on eTMF day-to-day activities

• Partner with R&D IT to support the strategic lifecycle of eTMF including, but not limited to version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management.

• Maintains the eTMF system including secure storage, retrieval, retention, and destruction per SOPs

• Act as point of contact for internal/ external audits and inspections, which may include supporting document retrieval during audit/inspection and speak to eTMF current state, history and associated system related processes.

• Manage and participate in eTMF system related initiatives as needed.

• Collaborates with TMF leadership and other relevant stakeholders on SOP, associated controlled documents and applicable eTMF system trainings.

Essential Functions

• Manage and drive to completion required daily eTMF system related activities

• Ensure eTMF system and associated process align with ICH-GCP, regulatory and Eisai SOPs

• Oversight of eTMF vendor(s) and related TMF setup and maintenance processes, eTMF user support and training.

• Engagement with Eisai functional and CRO stakeholders to ensure eTMF users are effectively utilizing the system as well as obtaining feedback and suggestions for user improvement to aid in delivering an inspection ready TMF

Partner with and manage third party vendors for contractor management and TMF services to ensure contracts/services provided adhere to contractual requirements.

• Demonstrated experience in the pharmaceutical industry, with in-depth knowledge of TMF process and clinical documentation and eTMF system management.

Requirements

• Bachelor's degree required, preferably in a related field of study with 8 years of relevant experience.

• Experience with Veeva Vault eTMF processes and systems is a must, including proficiency in writing test scripts and understanding of system configuration management concepts.

• Must have a detailed knowledge of domestic and international regulatory requirements (including ICH and GCP guidelines)

• Expertise within eTMF system related inspection readiness activities.

• Must have good understanding of computer systems validation and related processes. 

• Knowledge and familiari