Provide clinical and technical support in hospital settings, collaborate with medical professionals, and maintain strong knowledge of electrophysiology products while ensuring effective utilization and training for optimal patient outcomes.

• Deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations. • Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts, and necessary approvals. • Check that all Regulatory Requirements are satisfied prior to trial/site initiation. • Ensure appropriate trial-specific training of CRO internal and external partners in line with Trial Training Plan. • In collaboration with Site Monitoring Lead and CRAs, ensure provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP, local regulations, BI SOPs, and adherence to trial protocol. • In collaboration with Site Monitoring Lead and CRAs, ensure adequate trial supply distribution to sites and timely data entry and cleaning, and on time Data Base Lock. • In collaboration with Trial Resource Specialist and with support from CRAs as appropriate, ensures collection of required documents, with timely, complete, and compliant archiving of all relevant documents for the eTMF and CTR Appendices. • Develop and maintain relationships with investigational sites and support CRAs in site contacts. • Report and provide Client updates, exchange critical information and share trial conduction information, within regulatory and compliance burdens. • Ensures all tasks are carried out in accordance with respective applicable SOPs, Business Practices, and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards. • Leads local CRO trial team to ensure integrity of trial conduct, assurance of patient safety, and that local component of trial is planned, conducted, and reported in line with regulatory requirements. • Works within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites.

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Essential Functions: - Oversight and management of the investigator site management and monitoring activities and the clinical monitoring teams for the assigned studies during the startup, execution, and close out phase of the study. - Functions as the lead site management resource for the client, investigational site, and the internal study team. - Ensures all monitoring activities for assigned projects are conducted according to study plans, relevant processes, and standard operating procedures (SOPs), GCP/ICH guidelines and other applicable regulations. - Provides input and supports development of study specific training material, and as appropriate provides study-specific training for the assigned clinical monitoring teams. - Oversees quality of clinical monitoring deliverables to clients and may conduct Quality Co-monitoring visits to ensure data quality and monitoring performance metrics are being met and develop solutions to optimize performance. - Responsible for the review and approval of study monitors’ site visit reports for the investigational sites on assigned studies within appropriate process requirements. - Works closely with clinical project manager and contributes to development of the clinical study specific plans as assigned. This includes but is not limited to clinical monitoring plan. Also responsible for creating and updating study specific tools and templates related to clinical site management and monitoring. - Assures compliance with study monitoring plan and collaborates with cross functional teams to ensure timely site initiate process. - Leads and supports any study specific requirements related to site performance, including but not limited to patient recruitment, site payments, study material needs, etc. - Works closely with clinical project management team and provides status report for onsite initiations, enrollment, visit schedules, trip report completion and any other status report as per the company and/or project specific requirements. - Works closely with the clinical project management team and the cross functional teams while keeping them apprised of any issues and seeking guidance as needed. - Maintains timely and effective communication among team members and site personnel as assigned. - May be responsible for the supervision and administrative oversight of the direct reports within the company expected framework. The direct report personnel may be clinical research associates (CRAs) or any other clinical team members if deemed appropriate. - Other duties as assigned. Necessary Skills and Abilities: - Demonstrated ability to perform CRA activities at an advanced level. - Demonstrated ability to lead a team of Clinical Operations. professionals in the successful execution of clinical trials. - Demonstrated ability to develop and maintain effective relationships with study site personnel and a track record of positively influencing them to achieve study goals. - Experience managing/mentoring and developing junior staff. Educational Requirements: - Bachelor’s degree preferred. Candidates with equivalent combination of education, training, and experience will be considered. Experience Requirements: - At least 5 years of prior Clinical Lead or Clinical Trial Management experience required, global clinical trial management experience is preferred. - Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. - Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials. - Extensive understanding of SOPs, Works Instructions, regional regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. #LI-JH1 #LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Senior Clinical Trial Associate - Brazil - FSP Sponsor Dedicated 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 We are currently seeking a Senior Clinical Trial Assistant (CTA) to join our diverse and dynamic team. As a Senior CTA at ICON Plc, you will play a key role in supporting the management and execution of clinical trials by handling a range of administrative and operational tasks. You will contribute to the smooth execution of clinical trials through efficient coordination, documentation, and communication with various stakeholders. What You Will Be Doing: - Providing administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records. - Assisting in the preparation and submission of regulatory documents and ensuring compliance with study protocols and regulatory requirements. - Collaborating with cross-functional teams to support trial operations and resolve any issues that arise during the course of the study. - Monitoring and tracking trial progress, including managing site communications and ensuring timely delivery of study materials. - Building and maintaining strong relationships with site staff and other stakeholders to facilitate smooth trial operations and support overall project success. Your Profile: - Advanced degree or certification in a relevant field such as life sciences, healthcare, or clinical research. - Extensive experience in a clinical trial support role, with a solid understanding of clinical trial processes and regulatory requirements. - Strong organizational and multitasking skills, with the ability to manage multiple tasks and projects effectively. - Proficiency in clinical trial management systems and relevant software, with a keen eye for detail in documentation and data management. - Excellent communication, interpersonal, and problem-solving skills, with the ability to work collaboratively with diverse teams and stakeholders. #LI-ED1 #LI-Remote 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 maximize savings and plan with confidence for the years ahead. - Global 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-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised 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 here. 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. Are you a current ICON Employee? Please click here to apply