The Study Design Specialist is responsible for creating comprehensive study builds from start to finish in the CRIO platform. This includes developing eSource from protocols and eCRFs, conducting post-build quality control reviews, and configuring budgets in our finance module. This individual will be considered an industry expert on the CRIO eSource and Finance modules. Responsibilities: - Utilize protocols, eCRF guidelines, pharmacy manuals, lab manuals, and other source documents to produce comprehensive builds for clients. - Interpret Clinical Trial Agreements and budgets for configuration in the CRIO finance module. - Design visit schedules and procedures for CTMS-only studies. - Complete client-requested edits and customizations. - Provide quality control reviews of client-built eSource and budget templates. - Manage complex trials to ensure all data is captured appropriately. - Modify standard templates to comply with protocol requirements. - Complete assignments on time. - Mentor and train current and new CRIO employees. Preferred Qualifications: - Experience with eSource, budget, and QC design in CRIO or other eSource/CTMS systems. - BS in medical or sciences field. - Experience as a Research Coordinator, Site Director, or Source Designer is a plus. Other Qualifications: - At least 1 year of healthcare experience. - Ability to interpret clinical trial protocols, source documents, and clinical trial agreements. - Knowledge of medical terminology and procedures. - Experience tracking study financials. - Strong people skills. - Detail-oriented with solid time management skills. - Well-organized, capable of establishing priorities, and executing tasks efficiently. Join us at CRIO and be part of a dynamic team dedicated to revolutionizing the clinical research industry. Apply today to embark on a rewarding career journey! Location & Travel: This position is fully remote. You can work anywhere in the US with the expectation of being available based on EST time zone. Benefits & Perks: - Work from anywhere - Unlimited PTO - 401k company match - Healthcare - Dental - Vision (Company Paid 100%) - Life insurance - Professional development - Work From Home Expense Reimbursement Equal Employment Opportunity: CRIO is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are made based on qualifications, merit, and business need without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other basis protected by federal, state, or local law. Disability Accommodation Statement: We are committed to providing reasonable accommodations to individuals with disabilities in the application and interview process. If you require accommodation to participate in the application process, please contact Human Resources to request assistance. Salary Range: $60,000 --- $70,000

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose: The Clinical Research Lead (CRL) is a strategic, field-based scientific leader responsible for driving the execution of Lilly clinical trials through exceptional investigator engagement and site performance management. This role is pivotal in ensuring Lilly’s portfolio is prioritized at high-performing sites and that trials are delivered with quality, speed, and insight. CRLs combine deep therapeutic and scientific knowledge with strategic agility to influence investigators, elevate protocol understanding, and co-develop tailored enrollment strategies in existing and new therapeutic areas. They serve as trusted partners to investigators—building strong, enduring relationships that improve return on enrollment and position Lilly as the sponsor of choice. CRLs partner closely with internal Lilly teams (including Clinical Development and Medical Affairs) to ensure that insights from the field shape development strategies and that development strategies are delivered with operational excellence and scientific clarity. Where applicable the CRL may also represent Investigator Engagement with Regulatory and External Bodies and help shape the country-level clinical trial landscape. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Clinical Investigator Management - Accountable for the full spectrum of investigator engagement from identification and qualification through enrollment, and support database lock, and study closeout - Serve as a clinical trial scientific ambassador, ensuring investigators deeply understand protocol intent, scientific rationale, and patient eligibility requirements - Develop and sustain strategic, high-trust relationships with investigators that span trials and therapeutic areas - Influence enrollment by co-creating tailored recruitment strategies aligned with site capabilities, patient population realities, and study objectives - Proactively find opportunities to reach new patients, accelerate enrollment and increase impact at priority sites, including for example, novel site models, community-based research initiatives etc - Capture and elevate critical insights from sites to optimize feasibility, protocol design, and study conduct Clinical Trial Management - Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data delivery - Leverage performance metrics to anticipate issues, intervene decisively, and maintain momentum toward clinical milestones - Drive inspection readiness as a continuous discipline across sites - Collaborate across functions and with vendor partners to resolve operational barriers, ensuring delivery with speed and quality - Maintain advanced understanding of local treatment paradigms and standard of care to influence strategic country/site selection and protocol localization - Provide oversight and quality assurance for vendor monitoring, escalating risks proactively - Where applicable, lead end-to-end management of Post-Marketing Safety Studies in compliance with local regulations Business Management and Engagement - Cultivate a portfolio of strategically aligned, high-impact investigators who consistently prioritize Lilly trials - Enable an exceptional investigator experience by being a responsive, knowledgeable, and valued scientific partner - Collaborate cross-functionally (e.g., Medical, Clinical, Study Delivery) to align on trial and site priorities, troubleshooting challenges with urgency and creativity - Conduct data-informed site prospecting and prioritization, contributing to trial competitiveness and regional strategic execution - Maintain scientific fluency and therapeutic expertise to lead meaningful, solutions-focused discussions with site personnel - Act as a key liaison between field teams, vendors, and investigators, ensuring alignment, shared purpose, and continuous knowledge transfer - Partner closely with field team colleagues to elevate the investigator and site experience, ensuring seamless collaboration and improving enrollment outcomes and Investigator relationships Country / Regulatory Engagement (where applicable) - Represent Investigator Engagement with regulatory agencies, ethics committees, and national research organizations in countries/territory - Influence the clinical trial ecosystem to improve regulatory agility and operational feasibility - Ensure that local requirements are translated into compliant, efficient trial execution and that Lilly’s internal processes reflect evolving country landscapes - Partner with leadership to identify and align regional initiatives and contribute to enterprise-wide clinical development success Minimum Qualification Requirements: - Bachelor’s degree or equivalent; strong preference for scientific, clinical, or health-related fields - Minimum 5 years of experience in clinical research or pharmaceutical industry with experience directly interacting with or working with HCPs and clinical sites - Minimum 2 years of relevant clinical or deep therapeutic area experience in Oncology - Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position - Currently reside in or be willing to relocate to our designated region Other Information/Additional Preferences: - Advanced degree in a scientific or clinical field (PharmD, PhD, MD, or MSc preferred) - Excellent understanding of GCP, clinical development and operations, and trial lifecycle - Demonstrated understanding of the therapeutic landscape and standards of care, with the ability to apply this knowledge to decision making - Proven ability to build credibility and influence HCP community through scientific acumen and relationship strength - Strategic approach with demonstrated success in delivering results in complex, fast-paced environments - Data-driven decision-making skills; ability to interpret and act on performance and operational metrics - Excellent communication, negotiation, and organizational skills - Deep therapeutic area knowledge and familiarity with local clinical research ecosystems - Experience directly influencing clinical site performance and driving enrollment success - Track record of delivering or exceeding performance targets in a collaborative matrix environment - Experience working with regulators or national bodies in support of clinical trial delivery - English fluency and proficiency in local language(s) as needed Travel Requirements: - Willingness to travel extensively (60-80%) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Clinical Study Associate 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 Clinical Associate to join our diverse and dynamic team. Working as a Clinical Study Associate exclusively assigned to a Pharmaceutical Company, you will perform tasks related to planning and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. You will provide support for critical day to day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with CTA Managers. You will collaborate with Clinical Operations Study Managers, study teams, and CROs to support clinical study activities, as defined by the clinical trial operating model. What you will be doing - Review study documentation. - Support Risk-Based monitoring. - Attend key team meetings. - Support inspection readiness and clinical trial systems. - Support vendor contract administration. - Support study close-out activities. Your profile - Bachelor's or advanced degree in Life Sciences, Health Sciences, or a related field. - 1-2 years experience in clinical research or healthcare, preferably within the pharmaceutical, biotechnology, or CRO industry. - Strong organizational and time management skills, with the ability to prioritize tasks and manage competing priorities effectively. - Strong attention to detail and problem-solving abilities, with a commitment to ensuring data accuracy, integrity, and compliance. - Excellent communication and interpersonal skills, with the ability to collaborate cross-functionally and build strong relationships. - Strong regulatory knowledge. - Fluent English. 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

Experienced CRA I - Sponsor Dedicated | Oncology / Neurology | 6 months of monitoring experience required (Home-Based - Maimi, FL) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes Conducts Source Document Review of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture Verifies site compliance with electronic data capture requirements - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets. - May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-out Knowledge of local requirements for real world late phase study designs Chart Abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff Qualifications: - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - 6 months of independent monitoring experience required - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 30% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $62,000.00 - $108,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.