• 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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Clinical Research Associate II (CRA II) – Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Clinical Research Associate II (CRA II) is responsible for facilitating in-house set up, activation, maintenance and closure of global clinical trials while gaining experience in clinical trial management processes. The CRA II will work closely with Investigators, Site Personnel and Vendors to ensure compliance with protocol and overall clinical objectives. In collaboration with the Clinical Management, the CRA II maintains consistent CRF data quality and discrepancy interpretation across sites. The CRA II will develop a basic understanding of the disease and indication. Essential Job Functions - May participate in study design and study set up activities - May conduct site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct - May prepare and/or review monitoring reports per SOPs - Supports development of study training and may provide study site training to site personnel - Provides study training to internal employees as applicable - Assists in development of CRF design, CRF guidelines and supports database development when applicable - Develops study tools and guidelines to be utilized by study sites - Develops basic knowledge of the process used to evaluate and select potential investigators and sites - Develops basic knowledge of the process used to evaluate and select potential vendors as applicable - Interacts with field monitors/CRO CRAs, investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues - May perform data in clinical database for completeness, accuracy and performs data trending as needed - May analyze and evaluate clinical data gathered during research - Drafts informed consents as applicable - Reviews site’s informed consent forms against the consent template for presence of all GCP requirements and protocol specific information and revises as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand - Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy - Ensures audit preparedness - May be responsible for tracking Safety Reports for assigned sites - Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports - May initiate device shipments to ensure that study supplies are adequate for assigned studies and accurately accounted throughout study - Develops basic knowledge of the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies - May be responsible for initiating and tracking quarterly site payments and reconciling study invoices - Communicates status of trial to manager and team - May be responsible for development or revision of SOPs or work instructions - Appropriately represents functional area - Other duties as assigned Requirements - Bachelor’s degree in a scientific field of study, with a minimum of 2 years directly supporting clinical research - Must have excellent verbal and written communication skills - High attention to detail and organizational skills are necessary - Basic understanding of peripheral and coronary artery disease and therapies preferred - Working knowledge of GCP, FDA, ISO and other applicable regulations - Ability to travel 10-20% domestically and internationally - Experience with EDC Data Management Systems - Ability to work in a fast-paced environment while managing multiple priorities - ACRP or SOCRA clinical research certification preferred - Operate as a team and/or independently while demonstrating flexibility to changing requirements Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Analytics Dashboards, Business Behavior, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials, Execution Focus, Laboratory Operations, Medical Knowledge, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics, Training Administration The anticipated base pay range for this position is : $87,000.00 - $140,300.00 Additional Description for Pay Transparency: Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits