Clinical Trial Manager
PRA Health Sciences
Req #: 120119
Type: Slovakia
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Overview: As a Clinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. CTM (Local Trial Manager) would be a primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulation and will maintain the quality and scientific integrity of clinical trials at a country level. Responsibilities: * Collaborates with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the country * Maintains expert country, site and protocol knowledge to support sites with questions as well as build strong site relationship * Partners with global, local country teams and study team to provide high level country strategy, drive study progress and country level study delivery. * Accountable for study deliverables and drives key decisions within set country. Job Function: * Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team * Supports country-level operational planning and accountable for site selection within assigned country/-ies. * Contributes and develops to program/study-specific materials - e.g., monitoring plan, study specific training documents. * Supports and contributes to Clinical Study Teams / Trial Management Teams as applicable, agenda driven, present at meetings. * Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers , Program Managers, CST or TMT, Development Operations Manager , etc) with oversight as required and ensures updates to relevant system * Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies. * Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training * Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisionin * Engages with local cluster team and local functions from a study perspective #LI-NR1 # LI- Remote Qualifications: - Local knowledge and expertise of regulatory environment, study start up process and associated timelines etc - Slovak and English fluent - Previous Clinical Trial Management experience required - BA/BS/BSc or Master's degree in scientific field preferred
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