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Teva Mgr Clinical Research India, Maharashtra, Navi Mumbai 508636782
12.01.2025
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How you’ll spend your day
- To be qualified by education, experience and training to assume responsibility for proper conduct of the study.
- Before study start:
- Comply with all applicable regulations, complete required forms.
- Comply with requirements of the GCP, EC/Sponsor agreed protocol and Lotus SOP’s applicable regulatory requirements and the ethical principles which have their origin in the declaration Of Helsinki
- Read and understand the IB or appropriate information on the drug prior to study start.
- Review and timely inputs on the protocol (eg dosing information, contradictions, warnings, precautions, adverse events, drug interaction) CRF, ICD and any other document as required for the study.
- Obtaining ethics committee approval and clarifying the issues / questions raised by the EC.
- Ensure that all study personnel assisting in the trial are aware of their obligations and have been trained on the protocol, study plan and trial related duties and functions respectively to perform duties assigned to them.
- Overall responsible for supervising 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.
- The Screening Physician shall co-ordinate screening activities in the respective clinical centers
- Responsible for screening volunteers for clinical study, and to decide the eligibility of a subject based on detailed history, physical examination, radiological, and electrocardiograph and laboratory parameters.
- Maintain the records of screening procedures as per GCP and other applicable regulatory requirement.
- Counsel subjects and refer to appropriate hospitals those who are found to have clinically significant abnormalities.
Your experience and qualifications
- MBBS OR MD
- 10+ Years of experience into BA/BE Studies
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