Pharm-Olam International

  • Data Manager I - India

    Job Locations IN-Bangalore
    ID
    2018-1858
    Category
    DM - Data Management
  • Overview

    About Pharm-Olam International:

     

    Pharm-Olam International 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:

     

    Job holder is accountable for the quality of work performed.

                        

    Under supervision, responsible for assisting in the completion of data management activities according to sponsor and contract requirements and in accordance with applicable standard operating procedures.

    Responsibilities

    • May attend meetings with the Sponsor and project team, for discussions relating to data management issues and provides status updates for the project with guidance from DPM.
    • May provide standard study metrics to the DPM and study team
    • Participate 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.
    • Assist in the coordination and may manage training for investigators, coordinators, data entry and CRAs on using the selected applications for data entry and cleaning, as applicable to study parameters.
    • Review, 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).
    • May coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of  medical terminology, as required.
    • 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
    • Assist in 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 Relationships:

     

    • Direct reporting line to Senior Manager, Data Management, with functional reporting line to ADPM or others as appropriate.
    • Collaborate with DPM, Pharm-Olam DMs and project team members.
    • Collaborate with Data Systems Team, SAS Programmers, Statisticians and Medical Writers (internal and/or external).
    • Collaborate with study CRA’s.
    • Support site investigators and study coordinators with regard to EDC training, problems and query resolution.

    Qualifications

    • Preferably a minimum of a Bachelor's degree in a Life Science, Pharmacy, Nursing, or related discipline or at least 1 year’s experience in clinical data management
    • 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 POI 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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