Clinical Data ManagerPharmaceutical

Aceh, Sumatra 14 January

Prulab Pharma Ltd.

  • Description

    Prulab Pharma Ltd. is seeking a Clinical Data Manager who will primarily be responsible for managing DM activities in the design, collection and lock of database for multiple phase I-IV clinical trials. As a member of the Biometrics group, the CDM will act as a member of clinical teams at Prulab Pharma and interface with external CROs and external vendors to fulfill many of his or her responsibilities.

    Roles and responsibilities include the following:

    *Serve as the Lead Data Manager on multiple studies
    *Design and modify eCRFs and EDC edit checks
    *Responsible for building, review and validation of clinical database
    *Create and maintain project DM documentations
    *Extract and monitor the trial data to identify issues
    *Manage CDM activities in CRO and other vendors
    *Mentor or train other junior members
    Position Requirements.

    Successful candidates will have the following background/experience:

    *Minimum of BS preferably in Health Sciences, Statistics, MIS or Informatics
    *Minimum of 3 experience in Clinical Data Management from CROs or Pharmaceutical companies
    *Experience in electronic data capture (EDC) systems
    *Knowledge of ICH/GCP guidelines and FDA regulations
    *Knowledge of industry data standards (CDISC, SDTM, CDASH)
    *Excellent organizational skills
    *Outstanding interpersonal, oral and written communication skills.

    Prulab Pharma offers employees a comprehensive benefits package that includes competitive salaries, comprehensive medical, dental and vision benefits, paid time off and volunteer hours, education assistance and much more.
  • Number of vacancies: 1
  • Requirements

  • Minumun level of education: Bachelor´s Degree
  • Years of experience: 5
  • Language(s): English
  • Knowledge: Microsoft Excel
  • Availability for travel: Yes
  • Availability for change of residence: Yes

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Ad summary

  • Clinical Data Manager

  • Recruiter

    Prulab Pharma Ltd.

  • Location

    Aceh, Sumatra

  • Work type

    Full Time

  • Type of contract

    Permanent contract

  • Apply now

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