10.0 - 14.0 years

14 - 20 Lacs

ahmedabad

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Job position: Project Manager Qualification: M. Pharm / Pharma D, Life science graduates Experience: 3-5 years of Project Management experience, Overall - 10-12 years of experience Location : Ahmedabad Detailed JD Overall Project Management of the assigned projects starting from project initiation till closure of the project. Ensure the project delivery as per defined quality standards, Protocol, service agreement, SOPs, GCP and other applicable guidelines. Manages multiple projects as assigned by HOD/CBCC Management. Coordinate with regulatory consultant/designee for regulatory submission and approval process. Coordinate with Sponsors throughout the project cycle for delivery of project as ...

Posted 1 month ago

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Qa Auditor Cliantha Research

8.0 - 13.0 years

8 - 18 Lacs

ahmedabad

Work from Office

Role & responsibilities Conduct external site audit (Late Phase) to ensure compliance with SOPs, Protocol, ICH GCP, and applicable regulatory requirements. Review of study documents like study protocol, inform consent, eCRF, Data management plan, study plans, Statistical analysis plan (SAP), clinical study report, etc. Audit study database in various clinical data management systems. Review and maintain QMS documents like change control, protocol deviation, etc. Review study TLFs (Table, listing and figure) Review validation documents of software used in clinical studies like clinical data management system (CDMS), eTMF, Clinical trial management system (CTMS), etc. Responsible for planning,...

Posted 3 months ago

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