Woodcliff Lake, NJ, United States
May 29, 2020
Sep 11, 2020
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. JOB SUMMARY The Associate Director of Data Management leads a team of data managers to ensure high quality deliverables from study start up to study close down for Phase II to Phase IV global clinical trials, according to SOPs and guidelines. This role has leadership of the data management group including performance management; training and mentorship; capacity planning; supervision of timelines; and contingency planning. The AD also leads process improvements initiatives and provides leadership during audits and inspections. The AD also leads and participates closely with other functions to implement new technologies & tools. AD stays current with industry standards and trends related to Data Management activities and ensure that processes are aligned. ESSENTIAL FUNCTIONS * Coaches, supports, manages and leads a team of data managers. * Establish and manage timelines & resources for delivery of data management related tasks. * Author and maintain data management related documents: Edit Checks, eCRF Completion Guidelines, Data Cleaning Plan, External Data Reconciliations, Investigator Meeting Training slides. * Lead and participate in the standardization of eCRF & Validation specifications. * Collaborates on development and review of initiatives, data standards, and SOP/SWP documents & metrics. * Training and Documentation Subject Matter Expert and working group lead. * Manage staffing capacity & resourcing * Manage Data Management staff, including hiring, training and mentoring, communicating expectations, and performance evaluation. REQUIREMENTS * BS degree in scientific or mathematical discipline, advanced degree preferred. * 10 years data management experience with global studies. * Knowledge of assigned therapeutic areas. * Management experience required. * Extensive experience managing CROs and BPOs. * Extensive experience in both in sourced studies and outsourced studies. * EDC experience in multiple systems - InForm, RAVE. * Understanding of Project Management Principles and/or PMP certification a Plus. * CCDM certification highly desirable. * Experience with CDISC/SDTM highly desirable. * Excellent communication skills (oral and written). * Demonstrated ability to learn quickly and work independently as well as collaboratively and plan and be proactive. * Extensive knowledge of clinical trials data management best practices and working knowledge of clinical data management systems. * Ability to understand and work with technical database specifications. 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: Right To WorkE-VERIFY PARTICIPATION
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Website : https://www.eisai.com