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 Manager, Clinical Operations manages 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 working in 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.
The Manager may lead the Eisai cross-functional team for designated study(ies) and/or may coordinate designated regional aspects of assigned global study(ies) under the oversight of the study Global Clinical Operations Lead. The role includes mentoring less experienced staff, although this position does not involve line management.
1. Managing study progress from start-up to close-out activities and end of study reporting 2. Assuring adherence to intended timelines in order to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs , identifying risks and implementing risk mitigation plans 3. Coordinating interdisciplinary activities throughout the study 4. Oversight and management of CRO and clinical vendors to ensure successful conduct of the clinical trial and to ensure data integrity and quality. 5. Effectively communicating with KOLs and Investigator site staff to support study delivery 6. Contributing to individual and team development through training initiatives and team building activities.
* 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 within 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-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 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 forecasting, tracking and reconciliation of study budgets * Excellent written and verbal communication skills. * Proficiency in MS Office, including MS Project
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