As a Senior CRA (ONC) Early Phases you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Roles and Responsibilities:Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.Develops meaningful site relationships through consistent collaborative communication and engagement.May participate in site feasibility and/or pre-trial site assessment visits.Attends/participates in investigator meetings as needed.May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possibleEnsure site compliance with study protocol, ICH-GCP, and local/country regulations.Ensure ongoing adequacy of site (facilities, staff) for trial conduct.Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEAInvolved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.Ensures site non-IMP study supplies are adequate for trial conduct.Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.Oversees the appropriate destruction of clinical supplies.Ensures site staff complete data entry and resolve queries within expected timelines.Ensures validity and completeness of data collected at trial sites.Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.Prepares trial sites for close out, conduct final close out visit.Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within guidelines.Required Qualifications:BA/BS degree with 5years of experience in pharmaceutical related drug development.Five years site monitoring and/or site management experience.Strong years of Oncology requiredStrong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.Strong critical thinking and problem solving skills.Strong IT skills in appropriate software and company systems.Willingness to travel up to 40% with overnight stay away from home.Proficient in speaking and writing English. Depending on hiring region, may also be required to be fluent in local language.Good written and oral communication.Preferred Qualifications:Experience working cross-functionally and in matrix teamsExperience in executing Lead CSM roleExperience mentoring more junior site monitors or site managersExperience working in early development studiesWhat 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 entitlementsA range of health insurance offerings to suit you and your family's needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal Employee Assistance Programme, TELUS Health, 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-beingLife assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among othersVisit our careers website to read more about the benefits of working at ICON: ICON, inclusion & belonging are fundamental to our culture and values. 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.. 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. #J-18808-Ljbffr

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.What will you be doing?We are looking for an experienced Clinical Research Associate (CRA)based inBelgium, for our client located in Vilvoorde.Although you are homebased as a CRA, the team regularly meets in the offices in Vilvoorde, but also for team-bounding activities outside work. Next to this you like travelling and having close contacts and excellent relationships with your sites.The Clinical Research Associate is ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical studies throughout the trial lifecycle.Key responsibilities include:Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines.To enable success in this position you will have:At least 1 year as an independent CRA, including conducting monitoring visits for clinical trials, from either a pharmaceutical company or a CRO environment.A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.You will be educated to degree level in a life science discipline or be a licensed healthcare professional.Fluency in Dutch, French and English is essentialScientific degree (BSc, MSc or PhD), have equivalent experience or be a licensed healthcare professional.Visit our careers website to read more about the benefits of working at ICON: ICON, inclusion & belonging are fundamental to our culture and values. 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.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-VV1#LI-Hybrid #J-18808-Ljbffr

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.As a Clinical Research Associate II at ICON, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP.You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.What you will be doing:Independent, proactive work to set up and monitor studies, complete reports and maintain documentationSubmitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissionsBalancing sponsor generated queriesTaking responsibility for study cost efficiencyPreparation and review of study documentation and feasibility studies for new proposalsPotential to assist in training and mentoring fellow CRAsYou are:Degree in medicine, science, or equivalentPrevious experience in a clinical research setting (e.g., as a Study Coordinator or Clinical Trial Assistant), with a solid understanding of study processes, site coordination, and regulatory requirements (ICH-GCP).Knowledge of ICH-GCP guidelines and ability to review and evaluate medical dataExcellent written and verbal communication in both English and GermanAbility to work to tight deadlinesAvailability to travel least 60% of the time (international and domestic -fly and drive) and should possess a valid driving licenseWhat 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 entitlementsA range of health insurance offerings to suit you and your family's needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal Employee Assistance Programme, TELUS Health, 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-beingLife assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among othersVisit our careers website to read more about the benefits of working at ICON: ICON, inclusion & belonging are fundamental to our culture and values. 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, 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 the application process, or in order to perform the essential functions of a position, please let us know through the form below. 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-RR1 #J-18808-Ljbffr

Beijing, CRAICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.What You Will Be Doing:Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.Your Profile:Advanced degree in a relevant field such as life sciences, nursing, or medicine.Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.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 entitlementsA range of health insurance offerings to suit you and your family's needs.Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.Life assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.Visit our careers site to read more about the benefits ICON offers.At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request hereInterested 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.Are you a current ICON Employee? Please click here to apply #J-18808-Ljbffr

RemoteICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.What You Will Be Doing:Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.Your Profile:Advanced degree in a relevant field such as life sciences, nursing, or medicine.Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.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 entitlementsA range of health insurance offerings to suit you and your family's needs.Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.Life assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.Visit our careers site to read more about the benefits ICON offers.At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request hereInterested 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.Are you a current ICON Employee? Please click here to apply #J-18808-Ljbffr

Experienced, high-performing, UK-based CRA/clinical research associate required to augment existing Oncology CRA team, for pharmaceutical and biotechnology company company partner.You will be partnering with a well-known global pharmaceutical company with a strong portfolio in cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation medicines.You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.Amongst other tasks, your main responsibilities will be to;Contribute to the selection of potential investigators.Provide the required monitoring visit reports within required timelinesDrive performance at the sites. Proactively identify study-related issues and escalate as appropriate.Perform source data verification according to SDV plan and ensure data query resolutionInitiate, monitor and close study sites in compliance with client Procedural Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.Train, support and advise Investigators and site staff in study related matters.We are looking for candidates with strong Oncology experience working in a clinical research monitoring capacity, and residing in Northern England or Midlands, UK (with appropriate right-to-work in the UK already granted, if applicable)#LI-Remote#LI-DB1 #J-18808-Ljbffr

Project Manager - Language Services - Mexico, Colombia, Chile, Peru and BrazilICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.As a Project Manager in ICON's Language Services department, you will be responsible for the successful execution of end-to-end translation and localization projects across a wide range of content types, with a strong focus on delivering high-quality outcomes for our pharmaceutical and clinical clients. Acting as a key liaison between clients, internal teams, and external vendors, you will combine operational execution with proactive client communication, financial oversight, and process improvement. This role requires a solid understanding of life sciences content, translation workflows, and project financials, as well as the ability to manage risks and prioritize effectively in a fast-paced, highly regulated environment.What you will be doingRecognizing, exemplifying and adhering to ICON's values which centers around our commitment to People, Clients and Performance.As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.Continuously developing awareness of the pharma / biotech / medical device industry landscape as it relates to department specific service-related trends and challenges and guides awareness for PCS staff.Actively supporting the growth and integration of service areas with ICON's Language Services. Proactively and independently expands knowledge base on constantly evolving industry trends and news and best practices.Managing the full lifecycle of Language Services projects, from scope definition and planning to delivery and post-project review.Gathering and validating client requirements, evaluating timelines and budgets, and determining project feasibility in collaboration with internal stakeholders.Coordinating cross-functional internal teams and external vendors to ensure timely, high-quality project execution aligned with client expectations and regulatory standards.Serving as the main point of contact for assigned clients, maintaining clear and proactive communication to manage updates, issues, and feedback.Tracking and managing project financials, including budget setup, cost tracking, and profitability monitoring throughout the project lifecycle.Identifying potential risks or scope changes early on and implement appropriate mitigation strategies to protect timelines, quality, and client satisfaction.Supporting process documentation and refinement by identifying inefficiencies or gaps and suggesting improvements or automation opportunities.Participating in department-level initiatives related to quality, efficiency, or cross-functional collaboration.Providing guidance and mentorship to more junior team members when needed, sharing knowledge and best practices.Collaborating with client services, quality, and operational teams to ensure alignment on service delivery and expectations.Your profile3+ years of experience in project management within translation, localization, or language services.Experience with Life Sciences translation projects (pharmaceutical, medical device, clinical, or biotech)Strong communication and stakeholder management skills, with experience in both client-facing and internal coordination roles.Proficiency in CAT tools, translation management systems, and project tracking software.Advanced proficiency in Microsoft Word, Excel, and other document formats (e.g., PDFs, XML, PowerPoint).#LI-FB2#LI-RemoteWhat 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 entitlementsA range of health insurance offerings to suit you and your family's needs.Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.Life assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.Visit our careers site to read more about the benefits ICON offers.At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request hereInterested 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.Are you a current ICON Employee? Please click here to apply #J-18808-Ljbffr