Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.
The Senior CRA, Clinical Operations assists the Clinical Operations Lead with the management of one or more Oncology clinical studies and will work collaboratively with internal and external team members supporting project activities.
This is an exciting opportunity for an individual with a proven track record of working in international study teams, including oversight of outsourced monitoring, internal cross-functional interactions and vendor oversight to join a dynamic team working to deliver high quality Oncology studies to time and budget.
The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. This individual supports the study team to ensure that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and Eisai’s standard operating procedures.
1. Having an oversight and management of outsourced monitoring by CROs to ensure successful conduct of the clinical trial and to ensure data integrity and quality, including identifying risks and implementing risk mitigation plans. 2. Supporting development of Monitoring Plans and oversight of compliance to monitoring quality, including schedules and metrics. 3. Providing input into development of a variety of study clinical documents such as Informed Consent Forms, review of IRB submission packages. 4. Proactively identifying and collaborating with CRO to resolve monitoring and site management issues that arise during study conduct; managing escalation of site related issues 5. Having an effective remote communication with KOLs and Investigator site staff to support study delivery, facilitating training of investigators and site staff 6. Supporting study progress from start-up to close-out activities and end of study reporting 7. Collaborating with cross-functional colleagues in order to achieve study goals, while ensuring compliance with ICH GCP guidelines, regulations and SOPs/SWPs 8. Interacting with assigned clinical vendors to ensure project delivery, data integrity and quality
Note that this is an office-based role, with occasional travel for co-monitoring visits related to oversight of outsourced monitoring activities.
* Bachelor’s degree in biological science, nursing, pharmacy or equivalent as a minimum. * Minimum 3 years of experience in the pharmaceutical industry in a position performing clinical operations functions. * Proven track record in oversight and coordination of monitoring within international study teams to deliver high quality Oncology studies, including development of monitoring plans and other study tools. * Previous pharma industry experience in Oncology, including awareness of current anti-tumour therapies is essential, and the individual should be at ease with tools such as RECIST criteria for tumour assessment and NCI Common Toxicity Criteria. * Demonstrated experience in the identification of emerging risks and the ability to collaboratively implement solutions within a multi-disciplinary team to help resolve challenges * Must possess excellent priority setting skills, as well as excellent organizational and interpersonal skills and flexibility to accommodate to rapidly changing priorities and deadlines * Solid analytical and problem solving skills. Excellent written and verbal communication skills. * Proficiency in MS Office
Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.
Eisai is an Equal Opportunity Employer – Minority / Female / Disability / Vet from tblHiringOrgDefaults