When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Program Management - May serve as a central Point of Contact (POC) between Senior Management and key Client personnel for contracted FSP Clinical Operations activities - May serve as a liaison to one or more Clients - May be responsible for Program Management activities related to one or more programs: - Oversees implementation, management, and closeout of Client programs, as required - Develops interview tools and conduct interviews with potential candidates based on Client requirements and selects staff for hire (with/without Client input) o Evaluates and deploys resources based on Client need, experience, and availability (workload capacity management, contingency planning), and manages/analyzes resource utilization to ensure cost effectiveness - Leads/contributes to Client-specific Operations meetings with Operations internal staff - Manages program issues, including problem identification, resolution, and escalation, as appropriate to FSP Clinical Operations and Client - Proactively manages program-level expectations, Key Performance Indicators (KPIs), and metrics - Oversees program transitions to ensure proper training, adequate project support, and to ensure the resource is aware of program expectations - Utilizes tools and systems to proactively collect, track, and analyze compliance/performance metrics - Adheres to quality standards and timelines within assigned areas in compliance with local regulations (i.e., FDA, EMA, etc.), ICH/GCPs, and SOPs Line Management - Manages FSP Clinical Operations assigned staff dependent upon Client structure and services - Oversees/Manages personnel and administrative issues for assigned FSP Clinical Operations staff (direct reports): - Provides staff with appropriate orientation, integration, guidance, and training on Client and FSP Clinical Operations systems and processes - Provides ongoing oversight of individual FSP Clinical Operations staff (collaborating with Client as required) - Facilitates, communicates, and addresses operational and/or performance issues including problem identification and resolution, coaching/mentoring of assigned staff, and escalation as appropriate to FSP Clinical Operations and Client - Supports and promotes staff professional development; assesses and provides opportunities for soft skills development - Conducts one on one meetings with direct reports, based on program requirements - Reviews and approves time and expenses in the applicable Time Management System - Conducts annual and ad hoc performance evaluations for all direct reports, as applicable - Hires, retains and develops a skilled, experienced, and motivated team - Minimizes regrettable turnover - Supports implementation of retention strategies for assigned staff o Oversees onboarding and offboarding of staff, as applicable o Reviews and approves content of curriculum vitaes (CVs), and conducts job description reviews for staff - Oversees training compliance of staff related to SOPs, systems, and processes - May provide mentoring to Associate level managers, as needed o Serves as a key communication liaison between FSP Clinical Operations Management and staff Collaboration - Interacts closely with interdepartmental functions (e.g., Training, Quality, Contracts, Recruiting, Finance, etc.), as well as Client representatives, depending upon scope of services and structure - Collaborates with Quality to ensure adherence to ICH/GCP guidelines - Observes, collects, and analyzes FSP Clinical Operational issues to discuss with/resolve on behalf of FSP Clinical Operations management - Assists FSP Clinical Operations management with program/projects as necessary - May collaborate with interdepartmental functions to create business proposals including Request for Information/Request for Proposals (RFI/RFPs) to meet each Client’s specifications - Supports efforts to identify opportunities for increased quality and efficiency Compliance with Parexel Standards - Complies with required training curriculum - Completes timesheets accurately as required - Submits expense reports as required - Updates CV as required - Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: - Ability to motivate direct reports - Effective interpersonal and communication skills, both written and verbal - Self-motivated, detail-oriented, and flexible - Well-developed planning, observation, prioritization, analytical, and problem-solving skills - Independent judgment and decision-making skills with respect to functional responsibilities including innovation, originality, and creativity - Strong computer skills with MS-Office products such as, but not limited to, Excel, Word, and PowerPoint - Proficient in written and spoken English required - Proficient in local language (as applicable), preferred Knowledge and Experience: - Minimum 5+ years of clinical operations experience; prior line management experience, or prior demonstrated leadership experience; FSP Clinical Operations experience preferred - Comprehensive knowledge of FDA and/or local regulations and ICH/GCP guidelines, and strong working knowledge of the drug development process and clinical trial operations - Previous experience working in a remote office environment and managing remote staff preferred Education: - Bachelor’s Degree or equivalent, or other required experience confirmed to be equivalent during the hiring process

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