At Eisai, caring for people is our work. Satisfying unmet medical needs and increasing benefits to patients, their families, and caregivers is Eisai's human health care (hhc) mission. This includes the development of innovative medicines-notably the discovery of the world's most widely used treatment for Alzheimer's disease. As a young company growing at a fast pace, Eisai offers its employees an opportunity to thrive. We understand and appreciate that our employees are our greatest asset, and are committed to providing a work environment that will attract and retain talent. Eisai enables and empowers all employees to make significant hhc contributions. That is our quest. That is our promise. That is what makes us Eisai.
The Senior Manager, Clinical Operations leads the cross-functional study team in managing one or more international clinical studies in Oncology, from Protocol Concept to Clinical Study Reporting and Disclosure.
This is an exciting opportunity for an individual with a proven track record of leading international study teams, including internal cross-functional coordination, CRO and vendor management 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 ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and Eisai's standard operating procedures.
Additionally, the Senior Manager manages performance and development of assigned direct report(s).
Managing all aspects of study progress from start-up to close-out activities and end of study reporting Preparing detailed project plan(s) with cross-functional input for all phases of the clinical study, assuring adherence to intended timelines in order to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs , identifying risks, procuring adequate resources and implementing risk mitigation plans Coordinating interdisciplinary activities throughout the study Oversight and management of CRO and clinical vendors to ensure successful conduct of the clinical trial and to ensure data integrity and quality. Effective communication with KOLs and Investigator site staff to support study delivery Contributing to individual and team development through training initiatives and team building activities. Manages performance and development of assigned direct report(s).
Bachelor's degree in biological science, nursing, pharmacy or equivalent as a minimum.
Minimum 5 years of experience in the pharmaceutical industry in a position performing clinical operations functions.
Proven track record as a clinical study manager leading international study teams, including internal cross-functional coordination and CRO and vendor management to deliver high quality Oncology studies to time and budget.
Previous pharma industry experience in Oncology, including awareness of current anti-tumor therapies is essential, and the individual should be at ease with tools such as RECIST criteria for tumor assessment and NCI Common Toxicity Criteria.
Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges
Must possess excellent project planning and priority setting skills, as well as excellent organizational and interpersonal skills and flexibility to accommodate to rapidly changing priorities and deadlines
Solid project and vendor management, analytical and problem solving skills.
Prior experience with development, tracking and reconciliation of study budgets
Excellent written and verbal communication skills.
Proficiency in MS Office, including MS Project
Line management experience is strongly preferred.
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: