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Assoc Dir Clinical Research

12.00 to 17.00 Years   Mumbai City   21 Nov, 2020
Watson Pharma Private Limited
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Centre Head:

  • Overall responsible for supervising the study related activities.
  • To provide timely inputs in the protocol and Informed Consent (for e.g. dosing information,contraindications, warnings, precautions, adverse events, and drug interactions) and thus ensure it is scientifically sound and gives a clear detailed description of trial related activities.
  • To submit protocol and other required study related documents to the Ethics Committee (as per the Ethics Committee SOP and ensure study commencement only after obtaining IEC and DCGI approval.
  • Ensure all conditions are fulfilled prior to commencement of the study in case of conditional approval of IEC.

Principal Investigator:

  • Overall responsible for supervising the study related activities.
  • To provide timely inputs in the protocol and Informed Consent (for e.g. dosing information, contraindications, warnings, precautions, adverse events, and drug interactions) and thus ensure it is scientifically sound and gives a clear detailed description of trial related activities.
  • To submit protocol and other required study related documents to the Ethics Committee (as per the Ethics Committee SOP and ensure study commencement only after obtaining IEC and DCGI approval.
  • Ensure all conditions are fulfilled prior to commencement of the study in case of conditional approval of IEC.
  • In case of US submission studies, complete form 1572 and 3454 as per SOP CL-G009.
  • To train and delegate trial related duties to all study personnel prior to start of the study or prior to performing any study specific activity and document the same in Form No.01 .
  • To ensure adequate facilities and resources are available for proper conduct of the study.
  • To ensure that the study is conducted as per the EC approved protocol, in-house SOP s and applicable regulatory requirements.
  • To inform the volunteer about the study and its procedures, encourage the volunteers to ask questions and answer their questions in their vernacular language (or with the help of transistor) prior to obtaining their written informed consent.
  • To ensure timely reporting of the following to all concerned
  • Deviations /to the protocol
  • Premature termination of the study.
  • Serious adverse event in a study.
  • To provide adequate medical management to the subjects and to review SAE reports.
  • To ensure proper accountability of investigational product (IP) from the time of receipt till the retention of drugs.
Qualifications
  • MBBS graduate with 12+ years of relevant experience.
,

Keyskills :
music makingadverse eventsinformed consentclinical researchmedical managementhr managementsopdcgisoundpharmaethicsinformtrainingresearchclinicalprotocoliecmedical

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