• Lead and develop a team of remote pre-screening CRCs • Assess and improve site-level patient pre-screening workflows • Own operational management of pre-screening activities • Serve as a critical bridge between leadership and frontline teams • Provide strategic oversight across the clinical research coordination function • Drive change management initiatives, partnering with stakeholders • Manage cross-functional relationships with clinical sites and internal partners • Act as an escalation point for complex operational and eligibility challenges • Accountable for team capacity management and workload allocation • Contribute to SOP development and continuous improvement efforts

• The Project Manager is responsible for the development, conduct and completion of research projects in accordance with the reasonable requirements of the originator of the project. • The Project Manager is responsible for all aspects of study management activities including cross functional team Leadership and co-ordination, Client communication/ management, financial management and Overall study delivery. • Project Manager must ensure studies are resourced effectively, managed efficiently, achieve project objectives within allocated budgets and agreed timelines and are conducted to the highest standards of Good Clinical Practice (GCP), regulatory requirements and applicable Standard Operating Procedures (SOP). • The Project Manager mentors/coaches Junior Project Management staff or Clinical Delivery Leads and assists their technical development.

Title: Senior Manager/Associate Director, Clinical Sciences, Oncology Location: Spring House United States Job Description: 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: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research - Non-MD Job Category: Scientific/Technology All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America Job Description: 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. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. 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 is currently searching for the best talent for a Senior Manager/Associate Director, Clinical Sciences, Oncology opening. This is a hybrid-based role (≥ three days onsite) at any of the locations listed within the job posting. The Senior Manager/Associate Director, Clinical Sciences, Oncology provides active scientific and strategic contributions and is responsible for contributing to the execution of clinical studies within the Therapeutic Area. This position involves collaborating with cross-functional teams, in close partnership with Study Responsible Physicians/Clinical Leads, to design, plan, and manage complex clinical trials, ensuring compliance with departmental, company, and regulatory standards. This role assists to contribute to the clinical development plan, involves in the development of clinical trial protocols and materials, supports the completion of clinical study reports and regulatory filings. As a core member of the clinical team, the Senior Manager/Associate Director manages matrix interactions among cross-functional members, assists with contributing to the evaluation of scientific opportunities, medical data monitoring, and drives process improvements to enhance trial efficiency and operational excellence. This role may manage direct reports, mentor colleagues, and foster a culture of continuous learning and development within the team. Essential Job Duties and Responsibilities - Contribute to the development and execution of clinical trial strategies and other study-related materials (e.g. case report forms, operational plans) and provide clinical representation for study-related review committees (e.g., protocol review committee). - Contribute to the execution of clinical strategies for clinical trial protocols, ensuring compliance with scientific, organizational and regulatory standards. - Oversee end-to-end delivery of a clinical trial protocol, including study design, initiation, medical data monitoring, data dissemination, and closeout activities. - Contribute to the management and coordination of activities with internal functional partners and external partners to ensure timely scientific and clinical execution of a clinical trial. - Contributes to the maintenance of the quality and integrity of clinical data, which is critical to the evaluation of study endpoints. - Support interaction and collaboration with investigators and study teams during the conduct of the trial(s). Lead training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes. - Contribute to the review, interpretation, and reporting of clinical trial data, supporting accuracy and integrity for health authority submissions. - Contribute to the preparation of documents for reporting clinical trial data (e.g., clinical study reports, patient narratives, investigator brochures, and periodic safety updates). - Collaborate with Study Responsible Scientist and Study Responsible Physician to assess and evaluate clinical trial data (i.e. adverse events, labs, medications, etc). Establish and define medical data review plan in partnership with Study Responsible Physician. Performs medical data monitoring/reporting and evaluates ongoing clinical trial data. - In partnership with Study Responsible Physician, act as a liaison between the company and clinical investigators, fostering collaborations with key opinion leaders and external advisors. - Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO, ARO). - Contribute to mentorship and training of junior team members, fostering a collaborative work environment. - Actively engage in opportunities to enhance clinical development and therapeutic area expertise. - Identify opportunities for process improvements and implement best practices in clinical trial execution. - Drive innovative research methods and operational strategies to enhance clinical development efficiency. - Collaborate with cross-functional partners to align clinical strategies with overall product development goals. - May participate in governance meetings, as appropriate, and cross-functional initiatives to promote business strategies and process improvements. - Prepare and present findings and results of clinical research at internal and external meetings, including regulatory body interactions. - May act as an author on scientific publications, as applicable, to contribute to clinical development practices and advancements. - Research and review medical literature and new technologies to support operational planning and scientific strategy implementation. - Integrate scientific and technological innovations into clinical trial designs, including biomarkers and digital health initiatives. Education and Experience - A minimum of a bachelor's degree in a scientific or related discipline is required. An advanced degree (e.g., MS, PharmD, PhD) is preferred. - Requires 6-9 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO or equivalent. - Oncology clinical trials experience preferred/required; Oncology research and development experience in the pharmaceutical industry or similar preferred/required - Strong understanding of clinical development processes, including trial design, protocol development, data analysis, regulatory guidelines, Good Clinical Practice (ICH/GCP), and study execution. - Demonstrated experience in managing critical aspects of clinical trials, from conception to closure, including data management and quality assurance practices. - Proven ability to interpret scientific literature and apply findings strategically within clinical projects. - Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint, and familiarity with generative artificial intelligence and clinical trial management software are advantageous. - Excellent written and verbal communication skills in English; ability to effectively present information to the stakeholders. - Strong interpersonal skills with a collaborative approach to working within cross-functional and global matrix teams. - Excellent organizational skills, ability to manage multiple tasks, prioritize effectively, and respond to changing business needs in a dynamic environment. - Proven analytical and problem-solving capabilities, with a detail-oriented mindset. - Ability to proactively identify program level issues/discussions that require escalation. - Ability to handle complex projects to overcome delays and obstacles to meet deadlines. - Experience in leading scientific teams and providing mentorship. - Strong project and time management skills; ability to develop timelines and ensure deliverables are met within project scopes. - Willingness to travel domestically and internationally, approximately 10%, as required by project needs. - A commitment to maintaining high ethical standards and fostering a culture of inclusivity in the workplace. 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. #LI-Hybrid Required Skills: Preferred Skills: Clinical Evaluations, Corrective and Preventive Action (CAPA), Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Tactical Planning, Technical Credibility The anticipated base pay range for this position is : $137,000.00 - $235,750.00 Additional Description for Pay Transparency: 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 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

Role Description 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. Your focus will be on coordinating clinical operations delivery, resolving issues, and developing team capability. - 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. Qualifications - 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. Benefits - 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. Company Description 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.