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: Danvers, Massachusetts, United States of America Job Description: We are searching for the best talent for Clinical Trial Coordinator II Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech #LI-Remote Responsibilities: - Support the management of trial-related systems such as the electronic Trial Master File (eTMF), including set up, maintenance and study close out. - Assures collection of essential clinical trial documents (i.e., CVs, Medical Licenses, Laboratory documentation, Financial Disclosures, Investigator Agreements) from investigational sites for efficient study start-up/site activation. - Support site start-up activities including reviewing study specific ICF templates, managing and communicating the status of sites and study’s start-up progress. - Plan, coordinate, and arrange study communications on and off-site with both internal and external partners. - Responsible for supporting the drafting of meeting agendas and detailed meeting minutes. - Maintain quality of collected regulatory documents, which include a precise QC process and proper review in accordance with Good Documentation Practices (GDP) when documents are received. - Communicate with investigator sites on collection of regulatory documents, Institutional Review Board submissions and other trial-related information. - Collaborate with multifunctional teams to resolve issues on collected essential documents as required per assigned studies. - Maintain accuracy of clinical trial registration information. - Provide assistance with communication and coordination for trial committee interactions, as needed. - Provide support during audits and inspections, as applicable. - Create, populate, review, approve, distribute, and track study materials as assigned by the Clinical Project Manager and Clinical Program Manager. - Accountable for accurate organization and maintenance of filing systems and tracking departmental documentation. - Regularly interact with high-level internal and external clients to coordinate the accomplishment of business needs. - Support efforts for and/or prepare a variety of correspondence and complex PowerPoint presentations. - Ability to perform additional responsibilities as requested. Qualifications: - Bachelor’s degree preferably in Life Sciences, Nursing, Business Administration or related medical/scientific field, or minimum 1-3 years relevant clinical research experience working at an Investigator Site, Sponsor or CRO. - Knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements. - Experience working with eTMFs and CTMS preferred. - Must be computer savvy and highly proficient in Microsoft Office: Word, PowerPoint, and Excel (i.e., format documents, presentations, spreadsheet formulas). - Able to work and thrive in a fast-paced team environment across cross-functional teams. - Highly organized, excellent prioritization, self-motivated, and detail oriented. - Demonstrate excellent communication, verbal and written, and interpersonal skills. - Ability to travel ~5%. 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. The anticipated base pay range for this position is: $92,000-$148,350 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. Employees and/or eligible dependents may be 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. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year. Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year. Holiday pay, including Floating Holidays – up to 13 days per calendar year. Work, Personal and Family Time - up to 40 hours per calendar year. 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, 16, 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. Required Skills: Preferred Skills: Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics

The Senior Manager, Global Trial Optimization will lead program or study level activities advising on our clinical development strategy, clinical study concepts, study protocols and operational plans that will enable predictable delivery of clinical programs and studies. You will develop and maintain relationships with our external experts facilitating a wide source of country and disease area intelligence used in study design and operational planning. A typical day may include the following: • Lead study level feasibility processes to generate high quality and timely data to inform study design, efficient geographical placement and operational planning. • Partner with teams during CRO led feasibility activities supporting validation of study and country level enrollment rates and study start up timelines to advise budget and baseline setting. • Supports the development and implementation of the Global Trial Optimization function through process initiatives and change management. • Partner with Data and Analytics function to review and identify appropriate central data sources. • Articulate the data story to teams based on country level feasibility and centrally derived data to support data driven decisions to improve protocol design • Project management of study level country landscape assessment activities and the collection of targeted feasibility information for early assessment of operational feasibility for conducting clinical trials. • Lead study level engagements to acquire, analyze and deliver high quality targeted information from external partners. • Prove input into continuous improvement activities to ensure consistency of process execution. • In partnership with Clinical Outsourcing provide functional input into the identification, qualification and relationship management of a range of vendors. • Develop and implement patient recruitment and retention tactics aligned with defined study strategy. • Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution • May require up to 20% travel To be considered a Bachelors degree in a related field with a minimum of 8 years of relevant industry experience within pharma/biotech, a CRO or consulting is required. Strong understanding and experience in operationalizing clinical development programs in a global setting from first-in-human to post-approval. Experience with feasibility. Must be a compelling communicator with ability to translate sophisticated messages to a variety of audiences. Additional requirements include: • Experience in using data to inform clinical strategy development • Ability to understand sophisticated business questions and develop effective solutions • Experience in process development, implementation and change management activities • Line management experience preferred Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $134,400.00 - $219,200.00

POSITION SUMMARY: The Senior Clinical Research Associate is responsible for the overall operational execution of clinical studies on one or more clinical projects/programs; from study concept through study completion. This position will perform required job duties with guidance from Clinical Trial Managers to ensure that trial timelines, costs, and quality metrics are met, and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements helps design and execute clinical research activities. PRIMARY RESPONSIBILITIES: - Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations - Develop study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required - Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight - Support the Clinical Data Management team in the design and content of case report forms, completion guidelines, including support and testing of an EDC - Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements - Overseeing clinical trial supplies related to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information - Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues - Monitor and track clinical trial progress, provide status updates to stakeholders - Develop new study monitoring plans, and monitor studies following study monitoring plans to identify protocol deviations or data discrepancies - Perform study activities including consent participants for research studies, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies where Natera functions as a Clinical Research Site. - Update Clinical Department SOPs with guidance from CTM and/or Director - Partner with other research and development groups at Natera to achieve deliverables - Perform other duties as assigned - This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job. - Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP. - Must maintain a current status on Natera training requirements including General Policies, Procedure Compliance, and security training - Employee must pass post offer criminal background check QUALIFICATIONS: - BA/BS degree in life sciences, related field, or equivalent - Minimum of 4 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields KNOWLEDGE, SKILLS AND ABILITIES: - Experience with clinical EDC systems, - Familiarity with the organization and structure of the Trial Master File (TMF) - Familiarity with bio sample management, sample processing, and biobanking best practices - Competency in SOPs, ICH-GCP, FDA Regulations - Proficiency in MS Word, Excel and PowerPoint - Demonstrated ability to work independently and lead projects - Demonstrated analytical skills and ability to identify complicated problems and propose solutions - Strong interpersonal skills and communication skills (both written and oral) - Excellent writing skills - Detail oriented, with solid organization and time management skills The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $99,400—$124,200 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.natera.com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

• Lead and manage the day-to-day operational execution of assigned cell therapy trials: study startup, site activation, enrollment, monitoring, close-out. • Develop and manage study timelines, budgets, forecasts, and related operational metrics. • Partner with external vendors / CROs / service providers (monitoring, labs, imaging, manufacturing/supply chain for cell product) to ensure high quality and timely deliverables. • Serve as the primary cross-functional operational contact for study teams (clinical operations, data management, biostatistics, regulatory, safety/pharmacovigilance, manufacturing, supply chain, medical affairs, quality). • Ensure compliance with regulatory and quality standards (FDA, EMA, ICH-GCP, relevant local regulations) and internal SOPs. • Participate in protocol development and amendments, informed consent form (ICF) review, CRF/data tool development, TMF (Trial Master File) setup & maintenance, monitoring plan, data review plan, drug/cell-product accountability and reconciliation. • Oversee site feasibility, selection, contracting, start-up (site initiation visits, training, enrollment & retention strategies) and close-out activities. • Monitor study progress, identify risks/issues (enrollment delays, monitor/vendor performance, budget overruns, data quality issues) and implement mitigation strategies. • Foster effective communication across study teams, escalate issues to senior leadership as needed. • Ensure preparation for audits/inspections, maintain high standards of documentation readiness. • Contribute to lessons-learned and process improvement initiatives, particularly around cell-therapy-specific operational challenges (e.g., chain of identity/chain of custody, logistics of product, unique site training). • Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations. • Develop study documents and tools including study, informed consent forms, project plans, budgets, study templates, and other materials as needed. • Vendor Management – Contribute to or lead cross-program vendor management activities • Contribute to SOP development within the Clinical Operations team