Study Medical Expert Ophthalmology
Bayer
ShangHai, China
1天前

YOUR TASKS AND RESPONSIBILITIES

  • Provides medical support for the study team
  • One of the Global contact persons during the course of the study for medical / safety questions

    Facilitates center identification and medical discussions with investigators

    Reviews patient medical data (blinded) during the course of the study to identify possible safety or data quality issues (consults with

    GSL, GCL and other relevant functions as needed).

    Reviews medical narratives and ensures thatthe narratives meet an acceptable medical standard in the Clinical Study Report (CSR)

    Supports the coding team for medical history, concomitant medications and adverse event coding

    In exceptional circumstances - as warranted by organizational needs the Study Medical Expert may work independently with full SME responsibilities

    If delegated by the Senior Study Medical Expert :

    Responsible for content of medical sections of protocol / amendments

    Participates in CRO selection to ensure that the CRO staff have the requisite subspecialty experience and defines outsourced medical

    activities

    Trains study team, monitors, site staff and CRO staff (if applicable) on medical aspects of the study, indication and compound

    Provides medical input at investigators' meetings and presents the medical background and rationale for the trial

    Writes the Medical review plan

    Gives input into the EDC checks and statistical tables / listings

    Reviews the statistical tables and interprets clinical data for the CSR

    Responsible for the content of the medical section of the CSR

  • Supports the Global Clinical Development team
  • Brings expertise on the indication studied

    Bringsin depth knowledge about the study and its patients

    Helps select the best countries to perform the trial

    Provides input into the project standards

    May support writing of study-related publication

  • If full SME responsibilities : Medical point of contact regarding the trial to outside bodies
  • Defending the trial to regulators, IRBs, etc.

    Preparing for DSMBs, steering committee and external consultants

    Able to answer and discuss in depth questions about the trial and its results

  • Point of reference for the Country Medical Contact person
  • Provides consistent replies across the countries / regions regarding the trial both to IRBs and health authorities

    Helps / guides the country medical contact people in their study specific local tasks

    Keeps updated medical FAQ lists for the study

  • Source of expert knowledge in the Therapeutic area / pathology
  • Keeps up to date with scientific progress / literature in the area

    Supports the participating countries in their needs of medical knowledge, e.g. through training / presentations to top KOLs etc.

    Participates in important local / regional / global advisory boards

    May help prepare / negotiate Health Authority Approvals and reimbursement

    WHO YOU ARE

  • Hold a degree of Medical Doctor; board certified specialist in
  • Ophthalmology

  • Have 3-5 years experience in Clinical development
  • Be fluent in English, both written and spoken
  • Be familiar with the regulatory and legal environment
  • Be a team player
  • Be sensitive to different global cultures / needs
  • Be a good communicator for both
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