Company Name : Religare SRL Diagnostics
Qualification : M.Sc. Biotechnology
Location : Mumbai
Experience : 0 - 1 Year
Job Description :
*Ensure project set up in accordance with the Study Protocol, Sponsor time frame for each contracted study & in compliance with all SOP's pertinent to the project set-up process.
*Following the timelines provided by the PE & the sponsor for completion of project setup prior to FPFV at SRL.
*Designing Lab. Manual, Customized TRF, Kits & Test SOPs prior to study initiation.
*Ensuring setup of Study Master to include of study related details pertaining to the protocol.
*Setting up of logistics prior to study initiation.
*Ensure 100% compliance of all relevant SOP's pertinent to the project set-up process without any deviations
*Ensuring amendment of lab records to meet the data lock requirement.
Ensuring that all study related documents are maintained in the respective study file & submit to the PE for QC.
Ensuring that all study related documents are maintained in the respective study file & submit to the PE for QC.
*Ensure 100% compliance of all pertinent SOP's for this process without any deviations.
*After receiving the study close out/data lock intimation from the Sponsor and QC from the PE forward the project files for Archival
*Interfacing with internal departments, PE & CRS-OM in resolving queries raised by site/sponsor in real time
*Addressing of issues & unanswered queries raised by site / sponsor.
TEAM SUPPORT
*On-going Support the PE, Fellow team members & CRS-OM for the smooth execution of the project & to build a strong CRS team
*On-going Support the PE, Fellow team members & CRS-OM for the smooth execution of the project & to build a strong CRS team
*Proactively assisting fellow team members & PE for the smooth execution of the project.
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