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Senior Manager, eTMF System
2 months ago
Eisai is seeking a highly skilled and experienced Senior Manager to lead our eTMF system management efforts. As a key member of our team, you will be responsible for overseeing the implementation and maintenance of our global eTMF system, ensuring compliance with regulatory requirements and ICH-GCP guidelines.
Key Responsibilities- 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.
- Collaborate with group members and contribute to positive team relationships, both locally and globally.
- 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.
- Demonstrated experience in the pharmaceutical industry, with in-depth knowledge of TMF process and clinical documentation and eTMF system management.
- 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 familiarity with industry workgroups and initiatives such as CDISC TMF Reference Model Group.
- Knowledge/understanding of technologies to support document collection and archiving.
- Administrative experience with management of SharePoint sites.
- Must have strong verbal, written and interpersonal communication skills, especially needed to work in and effectively manage a cross-functional team.
- Ability to drive cross-functional projects with conflicting priorities.
- Ability to work with individuals from a wide range of cultures.
- Must be very detail oriented and possess excellent organizational and time management skills.
- Ability to work both independently and as part of a team, both within direct and matrix environments with IT and business.
- Must have strong analytical and problem-solving skills.
- Proficient computer skills, esp. using MS Office.
Eisai is 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. We are committed to satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers.
What We OfferEisai offers a competitive salary range of $114,600-$150,500, as well as opportunities for professional growth and development. We are an equal opportunity employer and are committed to diversity and inclusion in the workplace.
