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
Please leave blank
Minimum of 400 (0) characters
Please leave blank
Good news! We have your resume on file, you can use our Quick Apply function to easily apply to this job.

Critical Need Jobs


Employer Information

Previous Page New Search

Very useful service, easy to work with. A lot of vacancies. Regular connection with subscribers. Hope it will help me in my job search in pharma/biotech.

Olga, Physician, Pediatric Endocrinologist

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. Licensed Clinical Psychologist

    Yonkers, NY
    The interdisciplinary health care team includes the facility's physicians, physical therapists (PT), occupational therapists (OT),...
  2. Equity Research and Data Analyst - VC-backed...

    New York, NY
    The firm buys and collects real-time data to synthesize and integrate with their own investment research in order to create data-d...
  3. Med/Surg -Detox - 163870

    Paterson, NJ
    Practices cost effective use of equipment and supplies. ... Full Time Clinical Director.
  4. HHA/Home Health Aide Jobs - Medical Insurance...

    Spring Valley, NY
    Home Health Aides - HHAs . As an extension of our own family, we offer our care team: Medical Insurance.
  5. Physical Therapists PT - 203664

    Ridgewood, NJ
    A Physical Therapist PT is needed to plan and administer treatment programs to assist patients with various mental and physical di...
  6. Design Researcher

    New York, NY
    The research were doing aspires to make meaningful improvements in the lives of the individuals, teams, and companies who use our ...
  7. Licensed Clinical Psychologist

    Bronx, NY
    The interdisciplinary health care team includes the facility's physicians, physical therapists (PT), occupational therapists (OT),...
  8. Associate Analyst, Equity Research

    New York, NY
    The role supports senior analysts across multiple sectors and will include conducting research studies of industry groups or speci...
  9. Research Associate - Fixed Income/Preferred...

    New York, NY
    Research Associate Fixed Income/Preferred Securities Department: Fixed Income/Preferreds Job Reports To: Portfolio Manager, EVP Ju...
  10. Quantitative Research | Execution & TCA

    New York, NY
    We are working with a large asset manager (>$1 trillion AUM) who are actively building their Equity Quantitative Analytics and Exe...
Browse all Clinical Research Jobs in New Jersey
Previous Page New Search