Senior Manager, eTMF Operations

2 weeks ago

Queens, New York, United States Eisai Full time

Company Overview:

Eisai is dedicated to addressing unmet medical needs and enhancing the healthcare experience for patients, their families, and caregivers through our human health care (hhc) mission. As a progressive pharmaceutical organization, we are making significant strides in neurology and oncology, with a robust focus on research and development. Our legacy includes the creation of numerous groundbreaking medications, including the world's most widely-used treatment for Alzheimer's disease. We are in search of passionate individuals who thrive in dynamic environments and aspire to make a meaningful impact.

Position Summary:

The Senior Manager will spearhead collaborative initiatives with R&D IT to deploy and sustain Eisai's global (Veeva) eTMF system. This role is pivotal in ensuring that the eTMF system aligns with Eisai's TMF vision and transformation strategies while adhering to ICH-GCP and regulatory standards. Additionally, the Senior Manager will provide leadership, guidance, and training on the eTMF system to guarantee effective utilization by users across active and archived studies. Responsibilities include overseeing daily global eTMF system activities related to clinical study Trial Master Files (TMF), ensuring readiness for regulatory inspections, and compliance with relevant laws and regulations. The eTMF system serves a global user base, including contract research organizations (CROs), necessitating careful management of access rights.

Key Responsibilities:

  • Oversee and drive daily eTMF system activities to completion.
  • Ensure alignment of the eTMF system and processes with ICH-GCP, regulatory requirements, and Eisai SOPs.
  • Manage eTMF vendors and oversee TMF setup and maintenance processes, including user support and training.
  • Engage with Eisai functional teams and CRO stakeholders to optimize eTMF usage and gather feedback for system enhancements.

The Senior Manager will foster collaborative relationships within the team, both locally and globally. This role will identify, lead, and engage in initiatives aimed at improving TMF systems and processes, including SOP reviews and TMF reporting, while serving as a subject matter expert in TMF Management.

Additional Responsibilities:

  • Provide oversight for eTMF system administration tasks, including study setup, country/site updates, and user access management.
  • Assess and resolve eTMF system issues in collaboration with relevant stakeholders, including R&D IT and eTMF vendors.
  • Offer strategic oversight of the eTMF System Management team and vendors regarding daily operations.
  • Collaborate with R&D IT to support the strategic lifecycle of eTMF, including version releases, system updates, validation, and user acceptance testing.
  • Maintain the eTMF system, ensuring secure storage, retrieval, retention, and destruction per SOPs.
  • Act as the primary contact for internal and external audits and inspections, supporting document retrieval and discussing the current state of the eTMF system.
  • Manage and participate in eTMF system initiatives as required.
  • Work with TMF leadership and stakeholders on SOPs and relevant eTMF training.
  • Partner with third-party vendors for contractor management and TMF services to ensure compliance with contractual obligations.

Qualifications:

  • Proven experience in the pharmaceutical sector, with comprehensive knowledge of TMF processes and clinical documentation.
  • Expertise in Veeva Vault eTMF processes and systems, including proficiency in test script writing and system configuration management.
  • Thorough understanding of domestic and international regulatory requirements, including ICH and GCP guidelines.
  • Experience in eTMF system inspection readiness activities.
  • Strong knowledge of computer systems validation and related processes.
  • Familiarity with industry initiatives such as the CDISC TMF Reference Model Group.
  • Understanding of technologies supporting document collection and archiving.
  • Administrative experience managing SharePoint sites.
  • Excellent verbal, written, and interpersonal communication skills, essential for managing cross-functional teams.
  • Ability to navigate cross-functional projects with competing priorities.
  • Capability to work effectively with diverse cultural backgrounds.
  • Detail-oriented with exceptional organizational and time management skills.
  • Ability to work independently and collaboratively within direct and matrix environments.
  • Strong analytical and problem-solving abilities.
  • Proficient in computer skills, particularly MS Office.

Salary Information:

The base salary range for the Senior Manager, eTMF Operations is between $114,600 and $150,500. This position is eligible for participation in the Eisai Inc. Annual Incentive Plan. Final compensation will be determined based on various factors, including experience, education, knowledge, and skills.

Equal Opportunity Employer:

Eisai is committed to equal opportunity in hiring and employment practices, ensuring that all candidates are considered without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability, or veteran status.

E-Verify Participation:

Eisai Inc. participates in E-Verify, an internet-based system that allows employers to verify the employment eligibility of new hires in the United States.

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