Local Study Manager
PL
PRA Health Sciences
Req #: 113639
Type: Poland
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Overview: ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Responsibilities: Study & Site Operations strategy * Supports Study Start-up Manager in the development of country/cluster/hub study * Delivery of quality data and compliance to quality standards * Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements * Conducts or coordinates local investigator meetings as needed and ensures relevant documentation of training is archived in the Trial Master File * Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, develops risk management plans and communicates/ escalates to global teams * Accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation * Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times * Escalation point for issues in monitoring visit reports (MVRs) for the assigned studies. * Responsible for evaluating trends identified in MVRs and communicating/escalating to global teams, as appropriate. Communicates with CRAs and their managers to ensure issue resolution in a timely manner * Proactively identifies risk and opportunities for the assigned studies within the country/cluster/hub and develops respective mitigation plans Initiation and conduct of trials * When requested by the Feasibility Manager supports the study feasibility by providing input to the study protocol, and operational aspects of the study * Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites and Country personnel * Drives the conduct of the study, (tracks status, maintains relevant reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track * Ensures recruitment targets are met and reviews enrolment at the site level * Responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan * Oversees local study team activities to achieve study timelines and quality execution * Leads/chairs country/cluster/hub study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies * Maintains oversight of country/cluster/hub level data management activities * Tracks that all study close-out activities are performed in a timely manner * Supports inspection readiness and submission preparation for monitoring related activities and ensures implementation of corrective actions within specified timelines Budget and productivity * Monitors the status of site budget and contract negotiations as well as the collection and review * of essential documents throughout study conduct * Tracks study budget with appropriate study budget responsible in Country. Ensures timely TCF * preparation and submission * Processes invoiceable items for site level clinical study activities to allow timely payments Qualifications: * Bachelor/ Master degree * At least 2 years of experience on the similar position * Knowledge / expertise of regulatory environment, study start up process and associated timelines etc. on regional level * Extensive knowledge of ICH/GCP regulations and guidelines * Project and Program management experience including oversight of study deliverable, budgets and timelines What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Private Health Incsurance * Flexible country-specific optional benefits Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. #LI-MC6 #LI-remote
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