职位描述

职位描述： Position Purpose:An experienced role. To collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. To monitor investigator sites in compliance with Pfizer SOPs, ICH/GCP and local laws so site performance targets are achieved and the company’s image with its external customers are enhanced. To drive quality standards by acting as a mentor and providing support to less-experienced colleagues. To oversee and supervise contract and Pfizer CRAs as required. To support the Lead of Site Management by performing specific operational tasks as defined by business need.Primary Duties (fundamental components of role—both strategic & operational):Monitoring?Conduct SDV and ensure clinical trials data are submitted to data management in a timely fashion.?Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues.Management of Investigator Sites?Proactively manage a number of studies and investigator sites commensurate with experience, so that studies are run efficiently and key study objectives are met (pro rata with available monitoring time).?Ensure studies are run in line with ICH/GCP, local laws and Pfizer SOPs and procedures.?Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.?Inform the PI and site staff of all issues.?Agree and develop corrective and preventative actions with PI and site personnel to close all open issues.?Responsible for all aspects of site management from collaboration on site selection to study closeout with appropriate mentoring and support.?Train site staff on the protocol, protocol amendments and Pfizer processes.?Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.?Interact with health care professionals in a manner, which enhances Pfizer’s credibility with the customer.Data Quality?Ensure that data monitored meets target quality standards.?Ensure that data are entered into Pfizer systems in a timely manner.Reporting?Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.?Ensure all issues are correctly identified and catalogued.?Proactively manage issues to appropriate closure.?Maintain accurate site-level information on corporate clinical trials registry.Documentation?Obtain critical information to enable generation of IIP documentation.?Assist CTA in gathering IIP documentation where required to ensure timely site set up.?Maintain the SMF and SMF log.?Maintenance of ELARA and/or PTMF to ensure audit trail is complete and accurate.?QC relevant documents in ELARA and/or PTMF in a timely manner.?Generate site monitoring reports.?Maintain all appropriate monitoring logs.Mentoring?Mentoring and supporting less experienced colleagues.?Mentoring, Coaching and supporting other team members.Supervision of Contract CRAs (as required)?Involvement in selection and supervision of contract CRAs (cCRAs) as required.?Ensure induction and appropriate Pfizer specific training of cCRAs is undertaken.?Plan cCRA resources in such a way that their time is utilised optimally.?To lead, motivate and drive the performance of cCRAs to achieve agreed objectives.?To ensure that monitoring and site management activities are carried out to the highest standards in accordance with the appropriate regulatory and legal framework and company SOPs.?Provision of ongoing feedback of performance issues to agencies/MSP.Performing specific delegated tasks?Perform designated tasks, delegated from the Monitoring Lead to the required standard.CRO oversight?To support oversight of monitoring by accompanied visits with CRAs including CRO/FSP/contractor staff as required.?Provide feedback to CRAs and Study Managers on issues identified.?Use findings and observations from oversight activities to proactively drive higher quality standards.Training & EducationRequired:?Life Science/Nursing graduate or equivalent with at least 5 years of Clinical Monitoring/Site Management experience?Experience of working across a variety of therapy areas and trial phases?Demonstrated ability to adopt and promote new processes and systems?Full driving licensePreferred:?Experience of mentoring/oversight?CRA management experience possibly via project management 职能类别： 临床研究员

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