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| Job Location | Mumbai (Maharashtra) |
| Education | Any Graduate |
| Salary | As per Industry Standards |
| Industry | Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial |
| Functional Area | Bio Tech/R&D/Scientist |
| EmploymentType | Full-time |
Job ID 266300BRPosition Title Clinical Trial AdministratorJob Description 1. Provide logistical support to the Project lead/Lead CRA for studymanagement in particular with clinical trial medication anddocumentation. Prepare Clinical Trial Medication Forecast andresponsible for completing the clinical trial packaging request.Advises external and internal partners on clinicalmedication and study documentation .2. Review and approve proforma invoice for all clinical supplies priorto shipment and ensure relevant documentation, and site logistics.3. Support in coordinating clinical trials with various partners, including CPOs and CROs withinternal and external vendors, government agencies (customs dept)for tracking and import of clinical trial supplies including studydrugs.4. Responsible for Import License renewal for drugs on a yearly basisin consultation with the CRA GHs/Lead CRAs for regulatory purposes5. Responsible for coordinating activities - local inventorymanagement, re-labeling of drug etc. at warehouse across all projectsas and when needed. Main-tain tracking sheets for receipt, properdistribution of study material, documenta-tion related to destructionof study drug supplies across all ICRO managed trials6. Develop project tracker for tracking information related toinventory and stock maintenance for study materials for all ICROprojects provide updates to man-agement on an as need basis7. Liaises with Global asset management in consultation with CRAs/CRAGH for import of laptops for EDC trials and ensures delivery of laptopsto sites prior to FPFV. Liaises with respective CRAs to ensurere-export of EDC laptops to asset management following site closeoutvisit.8. Responsible for re-export of all applicable clinical supplies byliaising with glob- al/local vendor and their counterparts.9. Back up for other CTAsSupport for study start up to clinical team:10. Assist with the Ethics / Regulatory Submissions by preparing of ECbinders under the guidance of respective CRAs.11. Set up and maintenance of the country Trial Master Files (C-TMF),Site Trial Master File (S-TMF) and Investigator Site File (ISF). Theset up and maintenance of the trial documentation files, study recordsand tracking systems including electronic documents in accordance withICH GCP and the company SOPs in such a way that any relevantinformation can be presented promptly during inter-nal or externalaudits as assigned by the respective CRA GH.12. Assist in preparation and dispatch of SIV kits to sites. Supportall CRAs in study start up activities across all sitesMinimum requirements Bachelors degree or equivalent experience Fluent English (oral and written). 1. Proven ability to coordinate, organize and com-municate 2. Computer literacy 3. Knowledge of clinical trialsDivision Global Drug DevelopmentBusiness Unit GDO GDDLocation IndiaSite MumbaiCompany/Legal Entity Nov Hltcr Shared Services IndFunctional Area Research & DevelopmentJob Type Full TimeEmployment Type Regular
Keyskills :
regulatorycragcpclinical trialsedcclinicalresearch development