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Eisai
Nutley, NJ, United States
24 days ago

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

This position is responsible for the overall management of clinical studies in multiple phases including, but not limited to, the development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filing.  He or she ensures effective communication across the functional groups, during all stages of the clinical studies, to ensure completion of study deliverables on time and on budget.  This position requires a detailed understanding of overall strategic direction; interrelationships and business needs.

Essential Functions

  • Manages all clinical aspects of study, including: assesses operational feasibility and recommends study execution plan; develops and manages comprehensive study timelines and metrics; participates in selection and management/oversight of external vendors; reviews vendor reports, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepares and presents project debriefings, as required; plans, executes, and leads study-specific meetings (e.g., Study Management Meetings, investigator meetings, Advisory Committee).
  • Uses operational and therapeutic expertise to optimize trial design and execution; works with the study team to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; prepares study-related documentation; provides input for the design of the ICF template, CRFs, monitoring conventions, edit checks, etc.
  • Prepares and/or reviews study-related documents (e.g., Study Operations Plan, Monitoring Plan, Laboratory Manual, CRF Completion Guidelines, and other study-specific documents or manuals).
  • Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
  • Selects sites and countries; develops relationships with investigators and site staff.
  • Develops and manages study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget.
  • Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs/SWPs; participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities
  • Daily interaction with study Medical Director and members of the cross-functional study team; leads the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.).
  • Contribute to individual and team development through training initiatives and team building activities.

Requirements

  • Bachelor’s degree in biological science, nursing, pharmacy or equivalent as a minimum.
  • Minimum 8 years experience in the pharmaceutical industry in a position performing clinical operations functions.
  • Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
  • Strong clinical study management skills.
  • Requires excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills.
  • Electronic data capture experience, particularly Inform, as a plus.
  • Global trial experience required.
  • Experience in Alzheimer’s Disease therapeutic area preferred, but not required.
  • 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 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
  JOB REQUIREMENTS: <img height=1 width=1 border=0 src=https://eisai.contacthr.com/105963859.jpg /> To apply for this position, please copy and paste the following link into your browser address bar: https://eisai.contacthr.com/105963859



Job Information

  • Job ID: 62871362
  • Location:
    Nutley, New Jersey, United States
  • Position Title: Associate Director, Clinical Operations - Neurology Business Group
  • Company Name For Job: Eisai
  • Job Function: Director of Clinical Program Development
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