Clinical Site Manager
US
PRA Health Sciences
Req #: 113462
Type: Hungary
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Overview: We are recruiting Hungary based Senior CRAs who are looking for a developmental role - with a strong ability to build relationships at site (involved in problem solving and data review). You will be partnering with a pharmaceutical company who are consistently delivering on their commitment to improve the lives of people living with severe neurological and immunological conditions. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact. Maximizing site performance and site engagement conducted clinical studies. Leveraging strong clinical operational and therapeutic expertise (scientific, clinical, disease states, and treatment alternatives knowledge within the therapeutic area(s)) to support execution of the clinical studies. Responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory requirements. Engages with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high quality investigative sites to support clinical development programs. Collaborate with internal and external stakeholders as well as third party vendors. Provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance. Evaluate, screen and develop high quality investigative sites to support clinical development programs Responsibilities: Site Engagement Deliverables: * Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Clinical Team and key internal stake holders throughout the life cycle of clinical trials * Support clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery oftrials * Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of and its activities thereby increasing their desire to partner with * Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to forums, boards and/or discussions * Interact/train new investigators to work on clinical trials Monitoring Deliverables: * Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites' performance regarding set-up, conduct and data collection * Primary contact for sites regarding study-related issues. * Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study. * Interact/train new investigators to work on clinical trials. * Attend key therapeutic trainings/meetings and/or industry trainings. * Support CPM in management of the study, including but not limited to: o Vendor management o Training o Logistics o Selection of sites o Maintenance of study tracking o Oversight of eTMF * Close cooperation with the Clinical Project Managers and members of the Clinicial Trial Teams to inform on all aspects of the clincial trial status at site. * Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities. * Support the development of key study documents including, but not limited to Case Report Form (CRFs), diaries, informed consent/participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial-related meetings. * Prepare and/or review monitoring tools, e.g. monitoring manual * Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials. * Review and approval of site regulatory packages * Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs. * Contributes to updates of clincial program information, e.g., annual safety updates, Investigator's Brochure, and on query resolution, as needed, etc. * Depending on trial setting: * Train appropriate internal and CRO personnel on trial-specific monitoring requirements. * Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data. * Conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate. * Utilising all applicable Decentralised Clinical Trial (DCT) methods. * Shares insights, innovation opportunities and patient needs internally to the team, through collaboration with the innovation/Technology Transformation Implementation (TTI) Teams. * Such other responsibilities and projects that the Company may assign, e.g., cooperation on SOPs. * In collaboration with CPM/study team, ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner. Qualifications: Qualifications: * A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role (e.g. clinical project manager, study director/coordinator, clinical research associate, patient/site engagement companies) * BS or MSc. degree in a life science/biological related field preferred. At least three years experience in monitoring of trials in clinical development environment, preferably in phase 2-4 if responsibility for phase 2-4. * Strong Knowledge of GCP and ICH Guidelines (UK experience). * #LI-Onsite #LI-OB1 Why Join? 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. Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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
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