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Sr Manager, Medical Data Scientist

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Company :
Eisai US

Location :
Woodcliff Lake, New Jersey

Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT

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Description :
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai s human healt 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 Under the guidance of the Head of Clinical Safety Data Review , the Sr. Manager, Coding & Clinical Data Review will manage and review serious adverse events from clinical databases to ensure completeness of patient data; review & provide guidance to data management and medical data specialists in reconciliation of adverse events between clinical and pharmacovigilance databases; guide medical data specialists in performing aggregate review of adverse events of special interest and assess discrepancies of study medication and adverse events action taken. This individual will ensure that study and task milestones are tracked and assignments are allocated appropriately. The role requires the ability to write narratives or case descriptions as required by regulatory agencies. Essential_Functions * Supervise members of the coding and clinical data review in their designated assignments * Review and approve CRF designs related to coding and safety related field of the CRF * Review and approve appropriate codes of reported terms in application systems if needed * Maintain coding guidelines and conventions/ safety data review guidelines and writing guidelines and narrative writing * Review and assist in SAE reconciliation to ensure relevant safety details are in the Clinical database * Provide guidance to data management in reconciliation of adverse event between clinical and pharmacovigilance database * Manage and review serious adverse events from clinical database to ensure completeness of patient data * Perform aggregate review of adverse events of special interest and assess discrepancies of study medication and adverse events action taken * Approve queries by clinical data review group and support clinical summary writing process as needed. Review clinical summaries prior to medical review ensuring accurate data is captured and the description of events are medically acceptable * Coordinates clinical summaries for regulatory submission * Participate in the development of standard procedures and related documents as appropriate * Collaborate with system administrators for issues relating to queries in InForm and Data Operations for listings and narrative templates * Participate in the development and implementation of department standards and documents as needed. Requirements * Master degree in medical or sciences field is required. * Minimum 7 years experience in Data review * At least 2 years experience in Coding * Experience in Clinical Research /Clinical Safety in Clinical Research desirable * Familiar with MedDRA and WHODD or other coding dictionary * Experience with Clinical trial Systems e.g. InForm or review tools like J-review/ I-review/Spot fire or any coding application is desirable * Experience in supporting Neurology and/or Oncology studies * Experience in writing narratives for submission and review of CSRs or submission 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. Please_Click_On_The_Following_Link_For_More_Information 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. Right To Work E-Verify Participation Show moreShow less