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 Support Job Category: Professional All Job Posting Locations: Arizona (Any City), California (Any City), Colorado (Any City), Idaho (Any City), Montana (Any City), Nebraska (Any City), Nevada (Any City), New Mexico (Any City), North Dakota (Any City), Oregon (Any City), Raritan, New Jersey, United States of America, South Dakota (Any City), Utah (Any City), Washington (Any City), Wyoming (Any City) Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Senior Site Manager - Oncology. This position can be located remotely in the West Region (WA, OR, CA, ID, NV, UT, AZ, MT, WY, CO, NM, ND, SD, NE) of the United States. The Associate Site Manager (Associate SM) will serve as the primary contact point between the Sponsor and the Investigational Site. The Associate SM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. This individual may assist with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. Partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training. Some supervision from a more Senior Site Manager (Senior SM or Lead SM) to help provide guidance. Principal Responsibilities: - Act as primary local company contact for assigned sites for specific trials. - Actively participate in site feasibility and/or Site Qualification Visits (SQVs). - Attend/participate in investigator meetings as needed. - Execute 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. Implementation of analytical risk-based monitoring model at the site level and work with the site to ensure timely resolution of issues found during monitoring visits. Occasionally may require assistance or oversight from Lead SM or LTM. - Ensure site staff are trained, and the corresponding training records are complete and accurate at any point during all trial phases. Collaborate closely with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe. - Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. - Ensure site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct. - Ensure that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. - Arrange for the appropriate destruction of clinical supplies. - Ensure site staff complete data entry and resolve queries within expected timelines. - Ensure accuracy, validity and completeness of data collected at trial sites. - Ensure that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents. - Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management. - Fully document trial related activities, in particular monitoring. Write visit reports and follow-up letters in accordance with the SOPs. Promptly communicate relevant status information and issues to appropriate stakeholders. - Review study files for completeness and ensure archiving retention requirements are met, including storage in a secure area at all times. - Collaborate with LTM for documenting and communicating site/study progress and issues to trial central team. - Active participation in regularly scheduled team meetings and trainings. Provide feedback as appropriate. May be asked to lead/provide leadership at these meetings. - Comply with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support role and responsibilities. - Works closely with LTM 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 and other visit types, e.g. Compliance Monitoring Visit (CMV). - Prepare trial sites for close out, conduct final close out visit. - Track costs at site level and ensure payments are made, if applicable. - Establish and maintain 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 Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission and notification processes as required/appropriate. - Act as a point of contact in site management practices. - May contribute to process improvement and training. Qualifications: - A minimum of a Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related scientific Discipline is required. - A minimum of 1 year of clinical trial monitoring experience is required. - Experience in the Oncology therapeutic area is preferred. - Experience with Phase II and Phase III Clinical Trials is preferred. - Basic working knowledge of GCPs, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures, including monitoring guidelines, is required. - Strong computer skills in appropriate software applications and related clinical systems required. - Must have strong written and oral communication skills. - Willingness to travel up to 60% with overnight stay away from home is required. - A valid Driver's License issued in one of the 50 United States and a good driving record is required. The anticipated base pay range for this position in the San Francisco Bay Area, CA is $87,000 to $140,300. The anticipated base pay range for this position in all other U.S. locations is $76,000 to $121,900. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. - Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). - This position is eligible to participate in the Company’s long-term incentive program. - 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 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 - Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member - Caregiver Leave - 10 days - Volunteer Leave - 4 days - Military Spouse Time-Off - 80 hours - For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on April 27, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications. 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time Management

• Manages staff, providing coaching, mentorship and work direction. • Conducts regular performance appraisals and career discussions with staff. • Facilitates employee career development. • Interviews, recruits and selects staff. • Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. • Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. • Ensures timeliness and accuracy of timesheets and expense reports. • Supports allocation activities per the local resourcing process. • Supports activities of project leads/functional leads to optimize the operational running of projects. • Raises appropriately any issues which may impact project deliverables at a country level. • Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. • Identifies training gaps and ensures that training requirements are met. • May contribute to development of training programs, where appropriate. • Assures adherence to good ethical and regulatory standards. • Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. • Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. • Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable. • Participates in process improvement/development initiatives. • Ensures understanding and facilitation of the risk-based monitoring approach. • May provide input into bids and contribute to the procurement of new business where required. • Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. • May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

• Provide end-to-end operational leadership for complex clinical trials from start-up through close-out, ensuring delivery on time, within budget, and in compliance with global regulations and company SOPs • Lead cross-functional study teams and drive alignment across Clinical Development, Regulatory, Biometrics, and external partners • Develop and execute enrollment, site management, and monitoring strategies to ensure high-quality trial conduct and performance • Oversee CRO and vendor performance, including KPI management, monitoring quality oversight, document review and approval, and vendor selection support • Partner with Data Management and Medical to conduct ongoing data review and ensure timely query resolution • Develop and manage key study documents and operational tools, including protocols, informed consent forms, project plans, budgets, and study materials. • Lead study-related training for investigators, site personnel, and internal teams. • Proactively identify, assess, and escalate operational risks with mitigation strategies and clear recommendations. • Mentor and support junior clinical operations staff, including potential dotted-line management responsibilities. • Travel up to 10% as required to support study oversight and site engagement

Manager of Clinical Operations 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 Manager, Clinical Operations at ICON, you will oversee the execution of clinical trials, ensuring that they are conducted efficiently, on time, and in compliance with regulatory requirements. What You Will Do: Your focus will be on coordinating clinical operations delivery, resolving issues, and developing team capability. Key responsibilities include: - Leading the operational planning and execution of clinical trials, ensuring adherence to protocols and timelines. - Engaging with cross-functional teams to optimize trial design and enhance operational efficiency throughout the clinical development process. - Monitoring trial progress and performance metrics, providing insights to inform decision-making and drive continuous improvement. - Mentoring and developing junior staff, fostering a culture of collaboration and excellence within the team. - Building strong relationships with internal and external stakeholders to facilitate smooth communication across clinical operations. Your Profile: You will have solid clinical operations experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience: - Bachelor's degree in a relevant scientific discipline or healthcare-related field - Extensive experience in managing clinical operations, with a solid understanding of regulatory requirements and industry standards. - Strong leadership skills with the ability to motivate and manage teams effectively in a dynamic environment. - Proficiency in project management tools and methodologies, with a keen focus on optimizing processes. - Excellent communication and interpersonal skills, with a proven ability to influence stakeholders and drive successful outcomes. - Willingness to travel as required (approximately 30%) 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