Full 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.
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.
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.
Support development of Monitoring Plans and oversight of compliance to monitoring quality, including schedules and metrics.
Provide input into development of a variety of study clinical documents such as Informed Consent Forms, review of IRB submission packages.
Proactively identify and collaborate with CRO to resolve monitoring and site management issues that arise during study conduct; manage escalation of site related issues
Effective remote communication with KOLs and Investigator site staff to support study delivery, facilitates training of investigators and site staff
Supports study progress from start-up to close-out activities and end of study reporting
Collaborating with cross-functional colleagues in order to achieve study goals, while ensuring compliance with ICH GCP guidelines, regulations and SOPs/SWPs
Interactions 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
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.
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