• Lead, plan, and execute clinical research activities in various indications • Ownership of planning and implementation of clinical development programs • Manage project-related budgets • Oversee education of investigators and study site personnel • Participate in leading clinical study teams • Monitor overall study integrity and communicate safety and efficacy data • Responsible for SAB and DSMB relationships • Present at program-related scientific, medical, and regulatory meetings • Develop and maintain relationships with academic investigators and pharmaceutical partners • Contribute to regulatory filings including authoring clinical sections • Partner with Drug Safety & Pharmacovigilance • Maintain high level of clinical awareness in disease area • Co-author manuscripts and collaborate with colleagues

CLINICAL TRIAL MANAGER - FUTURE ROLES Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes Conducts Source Document Review of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture Verifies site compliance with electronic data capture requirements - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets. - May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-out Knowledge of local requirements for real world late phase study designs Chart Abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff Qualifications: - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 75% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Site Activation - Futures Needs - (Brazil) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Core Responsibilities •General – Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager. •Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified. •Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. •Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance. •Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements. •Responsible for one or more of the following functions at the country level: - Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAM. May serve as a point of contact for the SAM/PM (or designee) during start-up on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. - Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with oversight from the SSU Country Manager. - May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/ site level. - Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial. - May be asked to perform: Local Investigator Contract and Budget Negotiator – Supports the SAM to agree on country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SAM lead with Sponsor until resolution of issues and contract execution. Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Band Level 3 Job Description Summary This is a Remote Based position. Candidates must be located near an airport (Utah, Colorado, Minnesota, Texas and Illinois highly desirable locations). The successful candidate will be required to travel up to 80% of the time. The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Pharma clinical trials within the country. The Senior CRA is responsible for delivering data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs. This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 80% travel. LI-#Remote Job Description Key Responsibilities: Trial Monitoring strategy: • Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis) Allocation, initiation and conduct of trials: • Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries • Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures • Facilitates the preparation and collection of site and country level documents • Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects and performs continuous training for amendments and new site personnel as required. • Conducts continuous monitoring activities (onsite and/or remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety. • Accountable for continuously updating all relevant electronic systems to perform job functions • Takes on the responsibility as SME (Subject Matter Expert) as needed Delivery of quality data and compliance to quality standards: • Monitors studies as per current legislations, ICH/GCP and Novartis standards • Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring. • Identifies, resolves & escalates issues appropriately • Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry • Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as well as Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to achieve key accountabilities •Partners with SSU CRA to ensure seamless transition of site responsibility Essential Requirements: • BS/BA degree. Scientific, Healthcare or other related field. • Excellent knowledge of the drug development process specifically clinical trial/research • Knowledge of international standards (GCP/ICH, FDA, EMEA) • Ability to manage multiple priorities and manage time efficiently. • Excellent Site management capabilities with demonstrated negotiating and problem-solving skills • Strong communicator and presentation skills (oral and written) • Fluent in both written and spoken English Desirable Requirements: • Minimum of 3 years’ experience in site monitoring strongly preferred • RLT, CAR T or Oncology experience a plus! EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. 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 send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings Salary Range $108,500.00 - $201,500.00 Skills Desired Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences