Overview

Reference Number: JO-2010-456879
Senior Data Science Manager
Rate: Negotiable
Job Type: Permanent
Location: United States

SENIOR DATA SCIENCE MANAGER

Location: New Jersey, USA
Salary: Competitive
Type: Permanent

An attractive opportunity has arisen to take a Senior Data Science Manager role at one of the worlds leading pharmaceutical companies specialising in Oncology and Neurology studies. The company in question has been in business for over 75 years, employs a diverse team of over 10000 people worldwide, has offices located around the globe and boasts annual revenue of over 5billion.

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

If this opportunity interests you and you would like to discuss this role in more detail please email your CV to sam.gibbons@clinicalprofessionals.co.uk

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