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| Job Location | Ahmedabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Overall site management of clinical trialsensuring that projects are progressing according to contract and defined quality standards, Protocol, SOPs, GCP and other applicable guidelines to fulfill local regulations. Ensures the communication to sites about the project scope of work, timeline and project goals, technical information, and input from PM throughout the project. Preparation of site visits includes, Site Qualification, Site Initiation, Site Monitoring, Site Closeout, Pre- audit etc. To perform, SQV and to prepare report within stipulated time To assist PM in developing project plan, including all elements listed in the project plan template as appropriate for the project (Project milestone and Timelines, Roles and Responsibilities, WBS, Communication Plan, Risk Analysis, monitoring plan, Quality Management etc.). To perform Site initiation visits which include ensuring each site has the trial materials and training of site staff to trial specific and industry standards with PM and to prepare reports. Interim monitoring visits Monitoring the trial conduct at sites throughout its duration, which will involve visiting the study sites at a predefined interval to assess that the study is being done in accordance with the protocol and Monitoring plan and that the human rights are not violated, source data verification, collecting completed CRFs from sites, IP accountability, creating monitoring reports other site visit reports. To circulate Newsletters prepared by PM to sites To perform Site closeout visits Performs site closeout visit to ensure that site has resolved all data queries, availability of updated site files, patient file and reconciliation of the Investigational product and other study supplies. To coordinate with sites for resolution of DCFs To circulate final study report to respective sites for EC notification archival To ensure that project is archived and all documentation returned to Sponsor as specified by the contract. Maintains documents regular contact with the study site team throughout the study duration to ensure protocol/ GCP compliance, trouble shooting. Back Office monitoring, follow up on queries, communication with DSMB, CEC. Assists investigator meeting including preparation, liaison, presentations and follow up. Ensure communication with sites for ethics committee notifications of Serious Adverse Events, Study Progress, Protocol Deviations, and Safety Reporting etc. Communicates progress of study and relevant information to Project Manager and other project team members. Maintains trial master file throughout study period, including but not limited to report AEs, annual IRB reports, EC Communications, correspondence. Supervise, train and mentor clinical staff and new recruits within Responsible for day to day administration of clinical trial activities. Prepares the project for archival as specified by contract at the end of study completion. Ensures compliance with the Quality Standard requirements of quality management system and relevant documentation and filing. Other duties as assigned by PM, Head- PM and DO.,
Keyskills :
site safety gcp documentation itemonitoring qualitymanagementsystem backoffice siteinitiation riskanalysis qualitystandards humanrights clinicalresearch sitevisits adverseevents sitemanagement