Get Clinical Research JobsGet Clinical Research Jobs

Medical Safety/Medical Coding/Pharmacovigilance/Medical Reviewer

Job Title: Sr. Manager, Clinical Safety and Medical Coding

Location: Woodcliff Lake, NJ

Job Description Under the guidance of the Head of Clinical Safety Data Review " Oncology Business Group, manage and review serious adverse events from clinical database to ensure completeness of patient data; review & provide guidance to data management in reconciliation of adverse event between clinical and pharmacovigilance databases; perform, review and/or approve medical coding activities of adverse events, medical history, concomitant therapies, procedures and any other medical fields as needed.

Responsibilities include but not limited to: supervise and review work performed by members of the coding group and clinical data review group; review and approve CRF designs related to coding for all oncology studies; review and approve appropriate codes of reported terms in application systems; maintain coding guidelines and conventions; ensure proper mapping of coded items for analysis; review and issue coding queries as appropriate. Manage process of dictionary upgrading; coordinate the maintenance of synonym lists and coding conventions. .

Review and assists in SAE reconciliation to ensure relevant safety details are in the Clinical database; approve queries by clinical data review group and support clinical summary writing process as needed.

Responsibility also includes participating in the development of standard procedures and related documents as appropriate; collaborates with System administrators for issues relating to coding systems and coding related issue in Clinical database. Coordinate and guide coding specialist in grouping of search terms (medication or AESI) needed for analysis; Coordinate ISS re-coding activities and work closely with data programmers.

Essential Functions

1. Supervise members of the coding and clinical data review in their designated assignments in Oncology studies across Oncology Business Group.
2. Manage and review serious adverse events from clinical database to ensure completeness of patient data;
3. Performs approval of terms, oversees coding query and coding listings for review to study directors and manage requests for grouping of terms e.g medications or AE
4. Review clinical summaries prior to medical review ensuring accurate data is captured and the description of events are medically acceptable
5. Provide guidance to data management in reconciliation of adverse event between clinical and pharmacovigilance database
6. Manages Oncology coding convention, dictionary versioning and maintains grouping of terms and synonym list
7. Coordinates Clinical summaries for regulatory submission
8. Participate in the development and implementation of department standards and documents as needed
Job Qualifications Medical Degree or equivalent is required.
Minimum 7 years experience in Coding
At least 2 years experience in data review
Experience in Clinical Research or Clinical Science or Pharmacovigilance desirable
Familiar with MedDRA and WHODD or other coding dictionary
Experience in managing CRO, global team
Experience with central coding application, DS navigator or any coding application, InForm desirable
Experience in supporting Oncology studies
Good news! We have your resume on file, you can use our Quick Apply function to easily apply to this job.

Employer Information

Previous Page New Search

I haven't filled any positions with this service. However, it's a matter of time before the right person applies through this service. I get applicants, but our requirements are very niche. I only interview about 5% of our applicants.

Jami Lieberman, Sr. Corporate Recruiter

Join 3,412 other Clinical Research Professionals receiving FREE weekly job listings to their inbox every week.

We value your privacy. We will not rent your email to anyone.

Browse other Clinical Research Jobs in New Jersey

  1. Clinical Research Scientist, Multiple Myeloma

    12.12.17 Summit, NJ
    , communicate as necessary to resolve data queries, draft/update/review data review plans, support Clinical...
  2. Physician / Psychiatry / New Jersey / Permanent...

    12.12.17 All Cities, NJ
    interested in clinical research as well as treat an adult population. Call is 1:5, back-up call only...
  3. Documentation Specialist/ Publisher - Regulatory...

    12.12.17 Woodcliff Lake, NJ
    Bachelors degree required At least 3 years working in the pharmaceutical industry in an R&D environment. Solid knowledge of cl...
  4. Regulatory Affairs Specialist - CMC

    12.12.17 Bridgewater, NJ
    Duties: Author Module 3 submission documentation according to eCTD requirements for New Drug Application (NDA) Prior Approval S...
  5. Clinical Trial Coordinator / Clinical Trial...

    12.12.17 Woodcliff Lake, NJ
    Summary: Basic understanding of clinical study processes, with specialized technical skills to deliver own work within the clini...
  6. Senior Clinical Project Assistant

    12.11.17 Bridgewater, NJ
    Duties: Craft and coordinate scientific communication flow between clinical franchises and provide input in the interaction betw...
  7. Clinical Procurement Manager - CRO/ HEOR/...

    12.11.17 East Hanover, NJ
    Duties: Lead the Strategic Sourcing process including defining scope of work, execution of RFIs and RFPs and creation of Task Or...
  8. Regional Clinical Research Associate

    12.12.17 Princeton, NJ
    organization committed to clinical excellence for the position of Regional Clinical Research Associate. The...
  9. Physician: Neurologist with Multiple Sclerosis...

    12.12.17 NJ
    accepting J1 or H1B visa candidates. You will be involved in clinical research studies with potential for...
  10. Pharmacokinetics Research Scientist

    12.12.17 Moorestown, NJ
    Moorestown, NJ CareKinesis Inc. is looking for a Pharmacokinetics Research Scientist who wants to...
Browse all Clinical Research Jobs in New Jersey
Previous Page New Search