{"id":969,"date":"2019-03-21T14:48:17","date_gmt":"2019-03-21T14:48:17","guid":{"rendered":"https:\/\/blog.clinicaltrials.at\/?page_id=969"},"modified":"2021-09-08T08:55:48","modified_gmt":"2021-09-08T08:55:48","slug":"project-management-2","status":"publish","type":"page","link":"https:\/\/clinicaltrials.at\/?page_id=969","title":{"rendered":"Project Management"},"content":{"rendered":"<ul style=\"line-height: 200%;\">\n \t<li><strong>Ensuring and coordinating a policy-compliant study, <\/strong>conducted in accordance with protocol, SOPs, local policies and legislation as well as ICH-GCP guidelines, quality and time management<\/li>\n \t<li>Appointed point-of-contact for the management team of the sponsor<\/li>\n \t<li><strong>Assistance in the selection and identification of\u00a0<\/strong><strong>suitable study sites<\/strong><\/li>\n \t<li>Organizing Investigator Meetings, Team Meetings and Study Workshops<\/li>\n \t<li>Budget and contract negotiations with study sites and involved institutions, resident doctors, vendors, etc.<\/li>\n \t<li><strong>Obtaining necessary insurance cover<\/strong> including budgetary negotiations with insurance agencies<\/li>\n \t<li>Preparation and implementation of <strong>study-specific\u00a0<\/strong><strong>training<\/strong><\/li>\n \t<li><strong>Preparation of all study documents<\/strong>, such as protocol synopsis, monitoring plan, and patient informed consent<\/li>\n \t<li>Qualitative verification of <strong>monitoring reports<\/strong><\/li>\n \t<li>Creation and monitoring of <strong>patient recruitment\u00a0<\/strong><strong>strategie<\/strong>s and patient enrolment plans<\/li>\n \t<li>Conducting co-visits at participating study sites for quality control and assurance<\/li>\n \t<li>Assistance in the preparation and execution of sponsor audits and inspections, including preparation of audit and inspection reports (CAPAs)<\/li>\n<\/ul>\n<!-- \/wp:post-content -->","protected":false},"excerpt":{"rendered":"<p>Ensuring and coordinating a policy-compliant study, conducted in accordance with protocol, SOPs, local policies and legislation as well as ICH-GCP guidelines, quality and time management Appointed point-of-contact for the management team of the sponsor Assistance in the selection and identification of\u00a0suitable study sites Organizing Investigator Meetings, Team Meetings and Study Workshops Budget and contract negotiations [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":63,"menu_order":8,"comment_status":"closed","ping_status":"closed","template":"templates\/template-full.php","meta":{"footnotes":""},"class_list":["post-969","page","type-page","status-publish","hentry","post"],"_links":{"self":[{"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/pages\/969","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=969"}],"version-history":[{"count":5,"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/pages\/969\/revisions"}],"predecessor-version":[{"id":2298,"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/pages\/969\/revisions\/2298"}],"up":[{"embeddable":true,"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=\/wp\/v2\/pages\/63"}],"wp:attachment":[{"href":"https:\/\/clinicaltrials.at\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=969"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}