Senior Clinical Research Assoc

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About Servier Pharmaceuticals: We're an organization, committed to modeling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description. SUMMARY OF ROLE: Ensure effective management and monitoring of clinical studies in the centers assigned by the Clinical Operations Project Manager (COPM) while respecting the protocol and in accordance with the standards of local regulatory authorities, the rules of Good Clinical Practice (ICH / GCP) and SERVIER Standard Operating Procedures (SOPs). This position will act as the COPM right hand in all project set up and management aspects and require a proven record of hands on experience in processes such as study feasibility and site qualification, TMF and ISF set up, creation of monitoring plans and preparation of IRB submission packages among other duties. Specific Responsibilities : Implement and monitor studies in assigned centers Take an active role in the creation of the study monitoring plan and other study related manuals and supportive documents Contribute to the site's identification and selection process Ensure the preparation of the center before the initiation visit and carry out the initiation visit and related follow up actions including initiation visit report and follow-up letter Participate in the development of the centers recruitment plan and closely monitor the progress of recruitment at the centers Asist in the creation of the Investigator site file Train investigators and research teams on the study protocol and related tasks Perform monitoring activities according to the study specific protocol and monitoring plan Monitor the progress of clinical trials and ensure the quality, reliability and authenticity of data collected according to protocol, Servier SOPs, regulatory requirements and GCPs. Check the validity and consistency of the data collected in the e-CRF; manage correction requests if necessary and supervise corrections Identify
About Servier Pharmaceuticals: We're an organization, committed to modeling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description. SUMMARY OF ROLE: Ensure effective management and monitoring of clinical studies in the centers assigned by the Clinical Operations Project Manager (COPM) while respecting the protocol and in accordance with the standards of local regulatory authorities, the rules of Good Clinical Practice (ICH / GCP) and SERVIER Standard Operating Procedures (SOPs). This position will act as the COPM right hand in all project set up and management aspects and require a proven record of hands on experience in processes such as study feasibility and site qualification, TMF and ISF set up, creation of monitoring plans and preparation of IRB submission packages among other duties. Specific Responsibilities : Implement and monitor studies in assigned centers Take an active role in the creation of the study monitoring plan and other study related manuals and supportive documents Contribute to the site's identification and selection process Ensure the preparation of the center before the initiation visit and carry out the initiation visit and related follow up actions including initiation visit report and follow-up letter Participate in the development of the centers recruitment plan and closely monitor the progress of recruitment at the centers Asist in the creation of the Investigator site file Train investigators and research teams on the study protocol and related tasks Perform monitoring activities according to the study specific protocol and monitoring plan Monitor the progress of clinical trials and ensure the quality, reliability and authenticity of data collected according to protocol, Servier SOPs, regulatory requirements and GCPs. Check the validity and consistency of the data collected in the e-CRF; manage correction requests if necessary and supervise corrections Identify
Contacte al anunciante