Summary The Business Operations Specialist is responsible for enabling clinical trial execution through a combination of supporting implementation and management of clinical trial systems (CTMS, Learning Management System (LMS), TMF, etc.) and clinical records management. This role ensures clinical systems and TMF activities are executed in compliance with Good Clinical Practice (GCP), ICH E6 guidelines, applicable regulatory requirements (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trial Directives), and Arcus SOPs. They work closely with cross-functional teams to support and assist operation of these systems to enhance clinical trial efficiency and utilize effectively as well as ensures TMF remains current, accurate, and inspection ready throughout the trial lifecycle. Responsibilities Clinical Systems Management - Support the support the selection, implementation, configuration, testing, maintenance, training, and closeout of clinical trial systems, including CTMS, eTMF, LMS, and related platforms. - Provide day-to-day system support, troubleshooting, and guidance to study teams to ensure effective and compliant system use. - Assist with user access management, training coordination, system integrations, and vendor/CRO oversight activities. - Perform data entry, reconciliation, and quality checks across clinical systems and tracking tools. - Maintain study, site, and personnel records, including data cleaning, standardization, and error resolution. - Develop and maintain metrics, dashboards, and reports to support operational oversight. - Analyze clinical business processes to identify gaps and opportunities for optimization and process improvement. Provide support to address existing and potential gaps in clinical systems. - Escalate system, data, or process risks and work cross functionally to resolve issues - Participate in and support activities related to audits, inspections, and inspection readiness/ preparedness. Clinical Records (TMF) Management - Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF - Acting as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs - Review and classify documents collected from internal and external sources - Reconcile essential documents to avoid duplication - Support study teams with the TMF quality review process - Perform QC and maintenance of eTMF for assigned studies - Perform data entry and reconciliation in various clinical systems and tracking tools - Provide input on revision of TMF related Work Instructions and SOPs - Support the management and oversight of the CRO study-specific trial master files - Support the coordination of the transfer of study-specific trial master files from the CRO - Follow up on quality findings - Manage paper document filing process for wet-signed documents including QC review and paper/electronic filing. - Participation in audit, inspection readiness preparation and inspection activities as needed - Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps in the eTMF - May provide training and mentoring activities for new and current staff - Develop metrics, reports, and TMF tools/trainings - Act as stand-in leading team meetings, managing team tasks as needed Qualifications - Bachelor’s or Associates degree (preferably in a scientific or related field) and 5+ years of experience in clinical operations, TMF management, clinical systems, or related roles within the pharmaceutical or biotechnology industry. - Demonstrated experience supporting clinical trial systems (e.g., CTMS, eTMF, LMS, EDC, IRT); Veeva Vault experience required. - Strong understanding of clinical trials, clinical trial processes and TMF requirements, including ICHGCP, GDP, and regulatory expectations. - Familiarity with the DIA TMF Reference Model and industry best practices. - Strong organizational, analytical, and problem-solving skills with high attention to detail. - Ability to manage multiple priorities in a fast paced, high-volume environment. - Strong communication and interpersonal skills; ability to collaborate effectively across functions and with external partners. - Proficiency with Microsoft Office and clinical trial management systems. - Team oriented, flexible, and able to work independently while maintaining integrity and high ethical standards. - Position may require occasional travel - Physical Requirements Office Setting - Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds. This role can be based at our Hayward, CA or Brisbane, CA location (preferred) or can be remote based. Arcus Biosciences is an equal opportunity employer. #LI-JS1 #LI-Remote

Position Summary Department: Information Technology Status: Full-Time Shift: Monday- Friday, afterhours and weekends as needed Location: Remote, will come on site in Orlando, FL as needed At Orlando Health, we are ordinary people with extraordinary individuality, working together to bring help, healing and hope to those we serve. By daily embodying our over 100-year legacy, we reinforce our reputation as a trusted and respected healthcare organization that delivers professional and compassionate care to our patients, families and communities. Through our award-winning hospitals and ERs, specialty institutes, urgent care centers, primary care practices and outpatient facilities, our 27,000+ team members serve communities that span Florida’s east to west coasts and beyond. ORLANDO HEALTH - BENEFITS & PERKS: All Inclusive Benefits (start day one) - Student loan repayment, tuition reimbursement, FREE college education programs, retirement savings, paid paternity leave, fertility benefits, back up elder and childcare, pet insurance, PTO/Holidays, and more for full time and part time employees. Forbes Recognizes Orlando Health as a Best-In-State Employer - Forbes has named Orlando Health as one of America's Best-In-State Employers for 2024. Orlando Health is the top healthcare organization in the Metro Orlando area to make the prestigious list. "We are proud to be named once again as a best place to work," said Karen Frenier, VP (HR). "This achievement reflects our positive culture and efforts to ensure that all team members feel respected, supported and valued. Employee-centric - Orlando Health has been selected as one of the “Best Places to Work in Healthcare” by Modern Healthcare Position Overview The Senior Clinical Informaticist, partners with clinical, administrative and analytics leadership to lead in the development and implementation of a methodology and strategic plan for clinical informatics in the organization. The partnership will entail collaboration with clinicians, health administrative leaders and IT teams. Following the strategic plan, the Clinical Informaticist leads stakeholders through the process of procurement, implementation, maintenance, and optimization of IT products. In addition, the Clinical Informaticist integrates knowledge of clinical workflows with an understanding of data and analytics to help identify and lead in the development of new solutions to existing healthcare problems. Leading multi-functional teams involving technical and clinical experts to anticipate identify, and help resolve challenges faced by the organization is essential. Responsibilities Essential Functions Building Relationships and supporting current IT products • Strong customer service orientation and ability to follow issues to resolution. • Builds strong relationships with stakeholders and team members across the continuum of care. • Acts as a liaison with the IT teams and the assigned business units requiring IT based solutions. • Communicates initiatives and outcomes and with stakeholder groups. • Coordinates the execution and use of IT products. • Provides in-person support for stakeholders related to the use and adoption of existing and new clinical technologies. • Provides effective level of clinical, business and technical support to assist the IT Operations and the IT Products teams in effectively supporting and maintaining mission critical IT products. New product request process • Effectively participates in Governance processes for new requests. • Collaborates with stakeholders to guide technology choices, • Translates technical concepts into operational and clinical terms to meet the needs of stakeholders. Analysis of current business processes • Leads teams that perform business and process analysis to align the clinical needs with information technology. • Evaluates workflow and makes recommendations for practice change enabled by utilization of IT products • Evaluates current information technologies to determine opportunities for optimization, enhancements and workflow changes to improve user experience and clinical outcomes. • Provides complex analysis and evaluation of systems, processes and workflows to ensure corporate system needs are met in a cost effective and timely manner. • Assists in the development of new business processes and workflow issues to ensure the best possible outcomes for patients and assists in making Orlando Health the best place to work. • Enables and facilitates clinical insights and actions to improve patient outcomes. • Reviews IT usage, services, technology, and department specific projects in order to identify, forecast and develop IT needs. Analytics • Collaborates with clinicians and health administrative leaders to develop meaningful analytics. • Works with the Software and Data Sciences teams to develop workflows that support existing algorithms, rules, and predictive analytics to continually enhance the value of information provided to users. • Provides critical analysis and evaluation of IT tools and recommends revision of clinical systems, process and workflow to ensure achievement of positive patient outcomes and Orlando Health goals. Staff Requirements • Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards. • Maintains compliance with all Orlando Health policies and procedures. • Participate in projects as needed and performs other duties as assigned. Other Related Functions • Ability to participate in multiple activities and tasks simultaneously. • Knowledge of current healthcare trends and developments and associated business needs in the clinical information technologies. • Knowledge of the deployment and usage of clinical information technologies and electronic medical record technologies. • Demonstrates knowledge of regulatory and agency requirements. • Maintains current knowledge of HIPAA, privacy and confidentiality standards to ensure both vendor and internally developed software are compliant. Qualifications Education/Training • Bachelor’s degree in Nursing, Healthcare Informatics, Healthcare Administration, or relevant related clinical or IT field, OR Associate’s degree plus four (4) years’ experience in related area of study • Strong verbal and written communication skills. Licensure/Certification Licensed clinician with current license in area of specialty by the Department of Health (i.e. RN, RRT, PT, etc.) required. Experience • Five (5) years of clinical analytics experience in an acute care or ambulatory patient setting, required. • Healthcare IT experience required.

We anticipate the application window for this opening will close on - 27 Mar 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Position can be remote in the United States. The Senior Medical Safety Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the product lifecycle. The position is primarily responsible for providing technical and clinical information regarding product usage and performance, specifically as it relates to patient safety. You will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. You will apply your medical knowledge, clinical expertise, and product knowledge to support patient safety through the application of: Medical Input: • Maintain medical knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas. • Leverage medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle where the Medical Safety role is defined. Medical Safety Assessments: • Evaluate events and potential safety signals identified through Quality, Clinical, and Regulatory related business unit processes. • Author high quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate. • Critically assess and escalate newly identified safety issues (suspected increase in severity and/or frequency of known events or new events with a causal relationship to the device) per business unit processes for investigation assessment and action. • Assist with obtaining input from external medical and subject matter experts on safety matters. • Complete qualitative and quantitative assessments of post market adverse events, medical significance, and recommendations for inclusion in regulatory annual reports. Safety Inquiries: • Provide evidence-based medical safety input, education and/or response to safety inquiries from internal or external stakeholders (e.g., external medical personnel or other third-parties, including regulatory agencies or health care organizations). Product and Therapy Knowledge: • Acquire and maintain proficient knowledge of assigned products and therapies, such as device design and function, product labeling, indications, mechanism of action, care pathways, and overall safety profile (i.e., hazards and harms). • Actively acquire and maintain knowledge of relevant scientific literature associated with assigned devices/therapies. Business Acumen: • Acquire and maintain advanced knowledge of applicable business unit policies/procedures, and relevant regulatory requirements and guidelines (e.g., ISO 14971, Application of Risk Management, ISO 13485, Quality Management Systems). • Maintain an advanced understanding of key business processes involving Medical Safety (e.g., risk management, post market vigilance). • Work effectively across the matrix • Develop solutions and lead opportunities to advance and improve safety practices. May lead other projects as assigned in part or in entirety that span outside of Medical Safety. Medical Communication and Influence: • Lead and influence evidence-based medical decision making across the matrix organization. • Provide strategic input and influence business strategies to optimize Medical Safety value. • Interpret, analyze, and effectively communicate medical assessment across a variety of levels and audiences. • Adapt verbal and written communication style to situational context. • Adapt to changing priorities and work demands. ** There will be up to 10% travel for this position. Minimum Requirements • 4+ years of clinical experience (2+ years with an advanced degree). • Active healthcare license with clinical knowledge and relevant patient care experience. • Bachelor’s degree or higher in a biologic science with preference towards healthcare or medical profession (e.g., nurse, nurse practitioner, physician assistant, or other related medical/scientific field). Nice to Have • Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications with a preference towards cranial and/or spinal surgical specialty experience. • Excellent verbal and written English communication skills • Good understanding of regulatory guidance from European Medicines Evaluation Agency (EMEA), Food and Drug Administration (FDA). • Proficient in Microsoft Office applications including Microsoft Word and Excel and ability to learn new document systems/solutions. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$107,200.00 - $160,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Job Description We are currently seeking Sr CRAs with 3+ years of monitoring with Oncology experience located in the North Central US. Travel is expected to be nationwide at times, target 65% remote visits, 4 visits per month, 6-8 DOS (including virtual and in person). Job Overview: The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line management responsibilities, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned. Summary of Responsibilities: - The statements below are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties. - Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned. - Responsible for all aspects of site management as prescribed in the project plans. - General On-Site Monitoring Responsibilities: - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. - Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. - Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. - Monitor data for missing or implausible data. - Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. - Ensure audit readiness at the site level. - Travel, including air travel, may be required and is an essential function of the job. - Prepare accurate and timely trip reports. - Manage small projects under the direction of a Project Manager/Director as assigned. - Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned. - Review progress of projects and initiate appropriate actions to achieve target objectives. - Organize and make presentations at Investigator Meetings. - Participate in the development of protocols and Case Report Forms as assigned. - Participate in writing clinical trial reports as assigned. - Interact with internal work groups to evaluate needs, resources, and timelines. - Act as contact for clinical trial supplies and other suppliers (vendors) as assigned. - Responsible for all aspects of registry management as prescribed in the project plans. - Undertake feasibility work when requested. - Conduct, report, and follow-up on Quality Control (QC) visits when requested. - Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned. - Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned. - Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. - Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management. - Assist with training, mentoring and development of new employees, e.g., co-monitoring. - Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned 29) Perform other duties as assigned by management. - All other duties as needed or assigned. Qualifications (Minimum Required): - University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology. - In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered. - Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries. - Thorough understanding of the drug development process. - Fluent in local office language and in English, both written and verbal. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): - Three (3) years of Clinical Monitoring experience. - Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs. - Advanced site monitoring skills. - Advanced study site management skills. - Advanced registry administration skills. - Ability to work with minimal supervision. - Good planning and organization skills. - Good computer skills with good working knowledge of a range of computer packages. - Advanced verbal and written communication skills. - Ability to train and supervise junior staff. - Ability to resolve project-related problems and prioritizes workload for self and team. - Ability to work within a project team. - Works efficiently and effectively in a matrix environment. - Valid Driver's License. Physical Demands/Work Environment: - Travel requirements: 60-80% overnight. What do you get? Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: - Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) - 401(K) - Paid time off (PTO) – Flex Plan - Employee recognition awards - Multiple ERG’s (employee resource groups) - Target Pay Range (based on title): $118 - $130K #LI - Remote Applications will be accepted on an ongoing basis. Work Environment: - Work is performed in an office environment with exposure to electrical office equipment. - Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: - Ability to sit for extended periods and operate a vehicle safely. - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. - Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. - Regular and consistent attendance. - Varied hours may be required. Learn more about our EEO & Accommodations request here.