CRA II, Core team, Malaysia (remote) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 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 Pharmacoepidemiology Practice (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 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. - Per 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 study 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 to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. 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. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. 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. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. 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. 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.

CRA II - Sr. CRA I, Core team, Malaysia (remote) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 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 Pharmacoepidemiology Practice (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 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. - Per 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 study 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 to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. 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. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. 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. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. 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. 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.

Our Mission Function Health is the AI operating system for health, designed to empower people to live 100 healthy years. We are redefining how individuals understand, measure, and improve their health by moving beyond reactive care and enabling proactive, data-driven insight into human biology. Function has been recognized as one of Fast Company’s Most Innovative Companies of 2024, and is venture-backed by Andreessen Horowitz (a16z). Hundreds of thousands of members have joined Function to take control of their health. Through advanced diagnostics, deep biomarker testing, longitudinal data, and AI-enabled insights, Function equips members with actionable intelligence to take control of both the quality and length of their lives. Function recently announced a $298M Series B and is entering its next chapter of growth. As we scale, the quality and durability of our People systems, data, and insights will directly shape our ability to attract, retain, and support exceptional talent. Function’s newly launched Medical Intelligence Lab (MIL) is charged with building the operating system that converts individual and population health data into health guidance. In essence, MIL is building a GPS for health — a system which understands where you have been, has mapped the health landscape around you, and steers you where you need to go to avoid disease and arrive at healthy longevity. MIL brings together engineers, scientists, physicians, and regulatory and operations experts to build medical world models, prediction models, and guidance models that combine the best of human and machine intelligence. Your Mission As a Machine Learning Engineer in MIL, you will build machine learning (ML) systems that analyze large-scale, multi-modal, longitudinal health data to generate actionable insights for Function users. These ML systems will identify connections between disparate types of data and will analyze the trajectory of that data over time to provide early warning of disease. You will collaborate closely with data engineers, data scientists, and clinical domain experts to ensure that ML systems are reliable, interpretable, and suitable for use in regulated settings involving protected health information. What you’ll do As a Machine Learning Engineer, you will: - Develop, train, evaluate, and deploy machine learning models using multimodal healthcare data (e.g., blood biomarkers, images, medical records). - Partner with data scientists and domain experts to translate clinically informed cohorts, labels, and features into ML-ready representations. - Build and own end-to-end ML workflows, including literature review/prototyping, feature generation, training/validation, inference, experiment tracking and reproducibility, deployment, and monitoring/drift detection. - Design modeling approaches for longitudinal healthcare data, capturing temporal patterns and handling evolving data distributions. - Define evaluation frameworks that prioritize robustness, calibration, interpretability, and stability across cohorts and time. - Contribute to best practices around responsible ML in healthcare, including documentation, auditability, and collaboration with clinical stakeholders. - Support experimentation while maintaining production-quality engineering standards. Who you are You enjoy working on complex, real-world problems where data is messy, signals are subtle, and correctness matters. You care about model behavior in production and value interpretability, reliability, and maintainability over quick wins. You’re comfortable collaborating cross-functionally and communicating clearly about tradeoffs, limitations, and failure modes. Key Requirements - 3+ years of experience building and deploying machine learning systems in production. - Strong proficiency in Python and ML frameworks, such as PyTorch, TensorFlow, and scikit-learn (PyTorch is preferred). - Experience with the full model lifecycle: training, evaluation, deployment, and monitoring. - Familiarity with multimodal and/or longitudinal/time-series data (tabular biomarkers, imaging-derived features, events over time, etc.). - Solid understanding of feature engineering, model validation, error analysis, and basic statistical thinking. - Ability to collaborate effectively with data engineering and data scientists in shared data environments. Nice-to-have - Experience working with healthcare, biomedical, or other regulated data. - Familiarity combining multiple different modalities (e.g., tabular + imaging features, signals + clinical records). - Experience with self-supervised learning and the development of large-scale foundation models. - Experience deploying models in cloud environments (AWS, Databricks, etc.). - Exposure to model interpretability techniques and monitoring strategies (drift, performance degradation, data quality checks). - Experience working in PHI-sensitive and compliance-driven environments. What’s in it for you? As a Machine Learning Engineer at Function Health, you will be part of a tight-knit team working to build the future of health. You’ll work on foundational ML systems that enable the next generation of health insights — with an emphasis on responsibility, rigor, and long-term impact. You’ll also have access to: - Stock options - Comprehensive health, dental, and vision plans for you and your family - Wellness and commuter benefits - Competitive vacation policy - A culture that emphasizes learning, collaboration, and thoughtful engineering - Remote work flexibility Why You'll Love Working With Us: We value our team at Function and offer a competitive salary and benefits package, flexible working hours, and a dynamic work environment where creativity and innovation are encouraged. If you are a highly motivated and experienced individual who is passionate about using technology to improve people’s lives, we would love to hear from you. At Function, we celebrate diversity and are committed to building a diverse and inclusive workforce. As an equal opportunity employer, we do not discriminate on the basis of race, color, gender identity, ancestry, religion, age, sexual orientation, national origin, disability, marital status, Veteran status, or any other occupationally irrelevant criteria. Join the Function Health team and become a part of our mission to build a healthier future for all. Discover more about us and how we're changing the face of healthcare at Function Health. Important Notice: Legitimate communication from the Function Health team will always come from an email address ending in @functionhealth.com. Function Health will never request personal information such as banking details or payment during the hiring process. Please be cautious of communications or job offers that come from other email domains, instant messaging platforms, or unsolicited calls. If you ever have doubts about the legitimacy of a communication, please reach out to us directly at talent@functionhealth.com.

The Machine Learning Engineer will have deep expertise in healthcare and pharmacy data. The focus of the role is on designing scalable, reliable, and compliant ML solutions that support improved patient outcomes, optimize pharmacy operations, and enable real-time, data-driven decision-making across the organization. ***This is a remote role, with interviews conducted onsite.*** About the Role: - Design, build, deploy, and maintain production-grade machine learning models and pipelines using healthcare and pharmacy data (claims, EHRs, prescription data, formulary data, etc.) - Develop robust end-to-end ML systems, including data ingestion, feature engineering, model training, validation, deployment, monitoring, and retraining - Productionize predictive models related to medication adherence, utilization forecasting, cost optimization, and patient outcomes - Collaborate closely with data scientists, pharmacy experts, clinicians, and engineering teams to translate business and clinical requirements into scalable ML solutions - Implement MLOps best practices, including CI/CD for ML, model versioning, experiment tracking, performance monitoring, and automated retraining - Optimize model performance, reliability, and latency for batch and/or real-time inference use cases - Ensure all ML systems comply with healthcare regulations (e.g., HIPAA) and internal data governance, security, and audit requirements - Contribute to ML architecture decisions, tooling selection, and platform improvements within the Azure ecosystem - Document ML systems and communicate technical designs and tradeoffs clearly to both technical and non-technical stakeholders About You: - Bachelor’s or Master’s degree in Computer Science, Machine Learning, Data Science, Engineering, or a related field; or equivalent practical experience - 3 years + of experience building and deploying machine learning systems in healthcare or pharmacy domains - Strong proficiency in Python for machine learning and software development - Solid experience with SQL and working with large-scale relational and cloud-based data stores - Hands-on experience implementing and operationalizing machine learning models in production environments - Experience with Azure cloud services for ML workloads - Familiarity with Databricks and distributed data processing frameworks - Experience with ML lifecycle tools for experimentation, deployment, and monitoring - Subject matter expert mindset with ability to work independently and work collaboratively to achieve high‑quality outcomes - Demonstrates compassion in supporting patients, partners, and team members - Strong interpersonal communication skills to collaborate effectively across cross functional teams - Applies resourcefulness to solve challenges effectively At Avita Care Solutions, compassionate care is at the heart of everything we do. Join Avita and get inspired to be the care that unlocks the full potential of health for all. We’re committed to promoting health equity by providing comprehensive, integrated access to pharmacy services, clinical care delivery and digital health through our individualized and culturally competent LGBTQ+, HIV, PrEP, and sexual wellness care. Avita is a proud member of the U.S. Business Action to End HIV and has been recognized multiple times by the Human Rights Campaign Foundation as a Best Place to Work for LGBTQ+ Equality. Avita is an Equal Opportunity Employer dedicated to building a diverse, inclusive, and authentic workplace. We welcome everyone by recruiting, hiring, and promoting individuals without regard to their sex, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, veteran status, or any other status protected by applicable law. Avita also provides reasonable accommodation for qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and any other state or local laws. Pay range: $140,000-$185,000 annually, based on credentials and geographic location. Avita Care Solutions offers a comprehensive benefits package: Healthcare benefits (medical, dental, vision) for eligible team members and their families, along with additional company paid and voluntary benefit offerings. Six company paid holidays and three personal floating holidays, paid time off (PTO), paid leaves - two weeks paid parental leave, bereavement, sick leave, time to vote and jury duty, award recognition program, professional learning and development opportunities. Company paid benefits – basic life and AD&D, Maven and Health Care Advocate Work/Life Balance Program, health/dependent flexible spending. Voluntary benefits – long and short-term disability, pet insurance, legal, accident, hospital indemnity, critical illness, whole and supplementary life insurance, identity theft protection, 401(K) retirement savings plan with company match. All benefits are subject to the applicable plan terms.