Job Description
1. Responsible for clinical study monitoring, preparation of SIV, SMR for all periods, SCV for BA/BE studies.
2. Prepare, organize, conduct and follow-up site evaluation visits, site initiation visits, routine monitoring and close out visits as per relevant study plan
3. Verify quality, accuracy of data. efficient resolve data and audits queries and issues
4. Adhere to the study protocol and study procedures manual, complete all reports accurately and within the predetermined timelines
5. Review of study related documents, maintaining the project files and records for regulatory audits.
6. Responsible for maintaining study files (TMFs) at sponsor site.
7. Responsible for review of Clinical study report
8. Well versed with regulatory requirement USFDA, EMEA, ANVISA, Health Canada, DCGI, CDSCO w.r.t BA/BE and clinical studies.
9. To assist team in CRO selection as per the SOP, quality and regulatory standards.
10. To coordinate effectively with all stakeholders (PM, regulatory department, BE center, Plant QA) for smooth conduct of clinical studies.
11. Adherence to ICH-GCP and any other regulatory guidelines and requirements including adverse events and serious adverse event reporting
12. Compliance with mandatory SOPs as agreed for the study.
13. Good communication skill and Performs other duties as assigned.
APPLY ONLINE
1. Responsible for clinical study monitoring, preparation of SIV, SMR for all periods, SCV for BA/BE studies.
2. Prepare, organize, conduct and follow-up site evaluation visits, site initiation visits, routine monitoring and close out visits as per relevant study plan
3. Verify quality, accuracy of data. efficient resolve data and audits queries and issues
4. Adhere to the study protocol and study procedures manual, complete all reports accurately and within the predetermined timelines
5. Review of study related documents, maintaining the project files and records for regulatory audits.
6. Responsible for maintaining study files (TMFs) at sponsor site.
7. Responsible for review of Clinical study report
8. Well versed with regulatory requirement USFDA, EMEA, ANVISA, Health Canada, DCGI, CDSCO w.r.t BA/BE and clinical studies.
9. To assist team in CRO selection as per the SOP, quality and regulatory standards.
10. To coordinate effectively with all stakeholders (PM, regulatory department, BE center, Plant QA) for smooth conduct of clinical studies.
11. Adherence to ICH-GCP and any other regulatory guidelines and requirements including adverse events and serious adverse event reporting
12. Compliance with mandatory SOPs as agreed for the study.
13. Good communication skill and Performs other duties as assigned.
APPLY ONLINE
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