Senior Clinical Trial Associate

Eisai
United States, New Jersey, Nutley
200 Metro Boulevard (Show on map)
Oct 04, 2025
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. Responsibilities Conduct clinical trial support activities related to assigned trials(including coordination and documentation, eTMF management and review, etc.) in accordance with regulatory requirements, independently. Proactively provide ongoing support to trials in terms of logistics management, support for sponsor oversight by the study team, and coordination with vendor teams & CROs. Run reports and review metrics on data entry, related coordination with other cross-functional team members. Support coordination between the study and site teams for day to day operational activities. Review and track regulatory and other essential documents, eTMF metrics, investigator database, clinical supplies and other study materials, and assimilate information to present to the Internal Study team and/ or Vendor / CRO. Qualifications Bachelor's degree in biological science, nursing, pharmacy or equivalent area. a minimum of 2 years of relevant experience working with multi-site, clinical trials. eTMF set-up and management; experience with Veeva eTMF preferred. Some experience working with vendors and vendor systems essential, CRO experience preferred. Experience managing cross functional communication, specially liaison between site and study teams. Some experience having used Electronic Data Capture systems. Some experience working with regulatory & compliance standards/guidelines including ICH-GCP. Eisai Salary Transparency Language: The hourly rate for the Senior Clinical Trial Associate is from :32-43 Under 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 https://us.eisai.com/careers-at-eisai/benefits. Certain 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 Work E-Verify Participation