Pharm-Olam, LLC

Medical Coding Associate

Job Locations IN-Bangalore
ID
2020-2239
Category
Medical Affairs & Pharmacovigilance

Overview

About Pharm-Olam, LLC:

 

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

 

Summary:

 

Under supervision, responsible for completion of coding and data management activities in accordance with applicable standard operating procedures, ICH-GCP guidelines and other applicable regulatory requirements.

Responsibilities

  • Code data (Adverse Events, Medications, Medical Histories, Physical Exams or sponsor specified fields) with coding dictionaries
  • Provides standard study metrics (including coding) to the DPM and study team
  • Work in strict adherence to SOPs as well as current ICH-GCP guidelines and other applicable standards required by Regulatory Authorities
  • Assist in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Standard Coding guidelines and conventions, User Acceptance Testing and Data Transfer Agreements/Specifications, and reconciliation plans
  • May attend meetings with the Sponsor and project team, for discussions relating to data coding issues and provides status updates for the project with guidance from DPM (Data Project Manager)
  • Review, freeze and/or lock data in accordance with Data Management control documents for accuracy, completeness, consistency and validity, generate queries as necessary to sites, as well as project team
  • Perform ongoing quality control and data review
  • Participate in the production/coordination of coding reports and listings for team reviews and DSMBs (Data Safety Monitoring Boards)
  • May assist in development and finalization of any third party transfer specifications for electronic database load both to and from Pharm-Olam
  • Maintain Data Management study documentation on ePOI in an ‘audit-ready’ status
  • Perform third party data reconciliation, including but not limited to SAE/AE, Electronic Data Files (EDF), central labs and IVR, against the clinical database and track issues to resolution
  • Participate in internal and external training courses, where required
  • Identify and recommend process improvements to management team

 

Working Relationships:

 

  • Direct reporting line to Medical Data Reviewer
  • Collaborate with Pharm-Olam DPMs, DMs and project team members
  • Work closely with Medical Data Reviewer/Medical Coder/Medical Monitor for ongoing coding, coding deliverables and timelines and communicate any coding issues or resource conflicts for coding
  • Collaborate with Data Systems Team, SAS Programmers, Statisticians and Medical Writers (internal and/or external)
  • Collaborate with study CRA’s

Qualifications

  • Preferably a minimum of a Bachelor's degree in a Life Science, Pharmacy, Nursing, or related discipline and/or combination of education and experience
  • 2 years of medical coding experience and familiar with data management processes
  • Knowledge of medical coding, data management validation principles, query process, and medical terminology required
  • Experience within the CRO industry
  • Proven knowledge of clinical data management process and Electronic Data Capture applications
  • Good communication skills: written and verbal English
  • Effective working knowledge of Microsoft Office Suite including Word and Excel
  • Demonstrated problem solving, analytical, organizational and time management skills
  • Demonstrated flexibility and ability to work well in a team environment
  • Full knowledge of clinical data flow and research design
  • Demonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and Pharm-Olam SOPs
  • Comprehension of study documentation standards including Trial Master File organization and archival processes
  • Awareness of data standards, preferably CDISC STDM

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