HR Services Firm at AgilityPro
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Manager - Clinical Trial (6-10 yrs)
The Clinical Trial Manager is accountable for the day-to-day operations and execution of clinical trials to ensure the trial activities are conducted per protocol, ICH-GCP and regulatory compliance. The person manages the full scope of proper study conduct; from protocol development to final report.
- Design, review, and management of all study documents since initiating of the site till notification of CSR to the ethics committee i.e. Protocol, ICF, eCRF/Paper CRF, patient card, study sheet, subject inclusion log, subject identification log etc, Maintenance of Trial Master File
- Assist the investigator in managing the clinical operations related to conduct of the trial (i.e. recruitment, Informed consent Procedure, visit coordination, sampling, visit scheduling etc.)
- Handling of specific measurement equipment for various skin measurement
- Supervision of study team, Facilitate feasibility studies and participate in site selection and qualification. Act as point of contact for client and regulatory agency
- Design study dossier and submission to IRB/ IEC/DCGI for study approval respectively when required Serve as point person at the clinical site for monitoring (if needed).
Qualification & Background :
- Preferably having a degree or diploma in Clinical Research or associated field.
- 6+ years of experience in Clinical Research in a team leading capacity.
- Interpersonal & leadership skills, Multi-tasking
- Ingenuity, creativity, and imagination
- Self-motivated and able to work with minimal supervision
- Have a highly energetic, flexible, and driven personality
