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Prinicipal Medical Writer

Bengaluru, KA
Job Code:
  • Biotechnology & Science
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Job Details

May attend meetings with the Sponsor and project team, for discussions relating to data management and data coding issues and provides status updates for the project with guidance from DPM (Data Project Manager).Provides standard study metrics (including coding) to the DPM and study teamParticipate in internal and external training courses, where required.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, Data Quality Checks Specification, User Acceptance Testing and Data Transfer Agreements/Specifications, reconciliation plans, data review & quality plans.May assist in the coordination and training for investigators, coordinators, data entry and CRAs on using the selected applications for data entry and cleaning, as applicable to study parameters.May review database validation documentation in conjunction with Data SystemsReview, freeze and/or lock data in accordance with DM 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 reports and listings for team reviews and DSMBs (Data Safety Monitoring Boards).Code data (Adverse Events, Medications, Medical Histories, Physical Exams or sponsor specified fields) with coding dictionaries.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.Identify and recommend process improvements to management team.Working RelationshipsDirect reporting line to Manager, Data Management, with functional reporting line to ADPM or others as appropriate.Collaborate with DPM, Pharm-Olam DMs and project team members.Work closely with Medical Data Review/ 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 CRAs.Support site investigators and study coordinators with regard to EDC training, problems and query resolution.Education Requirements and QualificationsPreferably a minimum of a Bachelor's degree in a Life Science, Pharmacy, Nursing, or related discipline3 years experience in clinical data management with 2 + year of medical coding experienceKnowledge of medical coding, data management validation principles, query process, and medical terminology requiredExperience within the CRO industryProven knowledge of clinical data management process and Electronic Data Capture applicationsGood communication skills written and verbal EnglishEffective working knowledge of Microsoft Office Suite including Word and ExcelDemonstrated problem solving, analytical, organizational and time management skillsDemonstrated flexibility and ability to work well in a team environmentFull knowledge of clinical data flow and research designDemonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and Pharm-Olam SOPsComprehension of study documentation standards including Trial Master File organization and archival processesAwareness of data standards, preferably CDISC STDM.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | Ph.D. (Doctorate)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 3-8


Chemical Research | Data Management/ Statistics | Documentation/ Medical Writing | Quality Assurance/ Control
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