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Pharm Olam Medical Coding Associate

0.00 to 3.00 Years   Bangalore   13 Jun, 2020
Pharm-Olam International
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

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 Bachelors 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
,

Keyskills :
cpc cpt icd mentoring research itemresponsetheory useracceptancetesting clinicaldatamanagement electronicdatacapture standardoperatingprocedures dataflow datacoding clinicaldata medicalcoding datastandards qualitycontrol datamanagement pr

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