Job description
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.
Job Summary
The Administrative Coordinator is responsible to provide administrative and clinical research study support.
Essential Functions
Clinical Trial Contributions:
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Tracks and maintains study information and reports on study progress as assigned
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Attends internal study team meetings; prepares study team agendas, responsible for taking meeting minutes and distributes study team agenda(s), meeting minutes and action items
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Performs eTMF assist with set-up requests
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Assists with filing and archiving project documentation in the eTMF within the defined timelines
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Performs eTMF internal reviews, reconciliation and study file archival
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Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision of the COL
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Contribute to inspection readiness, including, but not limited to, creating and updating various folders and trackers for the eTMF, BIMO checklists, study team lists (internal, CRO and vendors), internal study team meetings, country specific documents and all other documents as requested by Clinical Operations
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Maintains sponsor team member staff assignment list for Eisai systems eg. eTMF, EDC, IRT
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Initiates, tracks and collates clinical trial documentation related to CSR appendices
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Track invoices and support the vendor reconciliation process
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Collaborates with Data Management at the end of studies to send out study data to the sites; tracks acknowledgement of receipt (AOR) for compliance
Administrative Contributions:
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Calendar management and coordination of meetings
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Plan meetings and take minutes as appropriate
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Coordinate domestic as well as international travel arrangements for department
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Process Invoices and prepare expense reports
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Maintains office supply inventory
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Maintain contact lists and department share point site
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Provide general support to visitors
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Liaise with other administrative staff to handle requests
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Provide support to other members of the department as needed
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Contributes to the development of the department’s administrative staff
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Interact with staff at all levels in a fast-paced environment
Requirements
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Bachelor’s Degree (US)
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Minimum 2 years experience
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Proficient in MS Office Suite (Outlooks, MS Teams, Power Point, Word, Excel)
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Basic understanding of study related documentations
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eTMF experience preferred
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Ability to work with global teams utilizing different media (email, virtual meetings, teleconferences)
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Strong verbal and written communication skills
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Strong customer service skills
Behavioral Competencies:
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Must have good attention to detail
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Self starter with the ability to multitask and show flexibility with changing project-specific priorities
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Strong verbal and written communication skills
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Demonstrate cooperative and professional behavior with colleagues and vendors
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Possess interpersonal skills to work with all functional areas and levels
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Good Organizational Skills
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Ability to work and manage stress
Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation
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Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
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