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 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-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 forecasting, tracking and reconciliation of study budgets. * Excellent written and verbal communication skills. * Proficiency in MS Office, including MS Project.
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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