Ruderfer & Associates
Biopharmaceutical Search Consultants

#2101

Senior Manager, Coding & Clinical Data Review

 Position:                    Senior Manager, Coding & Clinical Data Review            Job #2101

Location:                   Northern, NJ

Compensation:         Based Upon Experience

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Job Summary:

Under the guidance of the Head of Clinical Safety Data Review – Oncology Business Group, 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.

Duties & Responsibilities:

  • Supervise members of the coding and clinical data review in their designated assignments in Oncology studies across Oncology Business Group

  • Review and approve CRF designs related to coding and safety related field of the CRF for all oncology studies

  • 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 

Qualifications:

  • 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 Oncology studies

  • Experience in writing narratives for submission and review of CSRs or submission documents

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