Clinical Trial Assistant (Onsite in Nutley - Hybrid)

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 Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates clinical study timelines. Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule. Ensures consistency of clinical study and processes across clinical trials. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets. Ensures study is conducted within clinical trial protocols. Monitors progress and follows up with team members and line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May develop recruitment strategy for the trial in program.ResponsibilitiesTracks and maintains study information and reports on study progress as assignedAttends internal study team meetings; prepares study team agendas, responsible for taking meeting minutes and distributes study team agenda(s), meeting minutes and action itemsPerforms eTMF assist with set-up requests andAssists with filing and archiving project documentation in the eTMF within the defined timelinesPerforms eTMF internal reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision of the COLProvides general enrollment figures to COL or leadership team as requestedContribute 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 OperationsMaintains sponsor team member staff assignment list for Eisai systems eg. eTMF, EDC, IRTAssist with tracking SAE safety reports, collating information and providing updates to the CROInitiates, tracks and collates clinical trial documentation related to CSR appendices.Act as central point of contact for the clinical team for designated projects, communications, and associated documentationDocument Creation and Management:Assist with creating, updating and maintaining project trackers in EPICProvides support for document preparation and follow-up (e.g. Informed Consent Form, eTMF fling plan, Co-Monitoring Plan)Creates Clinical Trial Agreement requests using the legal tracker and follows-up on original agreements and amendments. Upload to Epic siteCoordinates reviews for essential materials such as ICFs and Co-monitoring plansCRO and Vendor Contributions:Assist in managing ancillary supplies with vendor/sitesAssists COL with action Item follow-upAttends CRO and vendor teleconferences as applicableReview regulatory packet for investigational product releaseProvide user access management support ; tracking certifications and maintain statuses of study team membersAssist with investigator meeting planning, including entering clinical meetings into Eisai internal systemsAttend investigator meeting when applicablePerforms other tasks or responsibilities as assignedFinancial Contributions:Track invoices and support the vendor reconciliation processAdhere to financial standards, guidelines and compliance requirementsTechnical Competencies:Functional development for resource planning. Become knowledgeable with the use of project tools and processes.Develop foundational knowledge of healthcare providers and KOL contributionsDevelop fundamental understanding for clinical trial execution, CRO responsibilities and the contributions of relevant functional areasTracks and completes individual expenditures (e.g., travel and expenses) as applicableFollows function’s financial standards, guidelines and compliance requirementsProficient with Outlook, Word, Excel and PowerPointFoundational understanding and usage of eTMF, Epic, EDGE, IRT, eDC and other Eisai internal systems as relevantQualificationsBachelor’s Degree (US)Proficient in MS outlook, word, power point and excelBasic understanding of study related documentationseTMF (Veeva) experience preferredAbility to work with global teams utilizing different media (email, virtual meetings, teleconferences)Must have good attention to detailAbility to multitask and show flexibility with changing project-specific prioritiesEffective communication across cross functional teams, vendors and CROsDemonstrate cooperative and professional behavior with colleagues and vendorsPossess interpersonal skills to work with all functional areas and levelsOrganizational Skills#LI-CCEisai Salary Transparency Language:The hourly rate for the Clinical Trial Assistant (Onsite in Nutley - Hybrid) is from :31-40Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit other benefits may be available for this position, please discuss any questions with your recruiter.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 WorkE-Verify Participation

Created: 2025-09-23