Clinical Study Operations Associate Jobs

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we're changing the way patients are diagnosed and treated for any disorder that affects brain physiology. We are seeking a Clinical Trial Operations Associate to join us in our mission to make brain monitoring easily accessible, interpretable, and actionable. In this role, you will collaborate with clinical research sites, project teams, and internal stakeholders to support the deployment of Beacon’s devices in clinical studies. This role focuses on study startup, site management, and live-study monitoring, ensuring the highest quality standards and compliance with regulatory requirements. This role is fully remote anywhere in the Pacific or Mountain Timezones in the U.S. and will require up to 5% travel. Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston, New York, and Paris. What success looks like Collaborate with project teams to support study startup activities. Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication. Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection. Monitor project progress, ensuring adherence to timelines, protocols, and quality standards. Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards. A

Opportunity Overview: The Cohere IT team administers systems with a holistic approach and is responsible for the study, design, development, implementation, support, and management of telecommunications and computer-based information systems and software. Providing support to our colleagues who utilize Cohere Health systems in their day-to-day responsibilities and operations is a key function of the IT team.It is our aim to ensure a friendly working environment while scaling solutions to provide secure and efficient technology to all Cohere employees. IT is the backbone of our business, the underlying structure that reinforces Cohere’s growth, and propels this world-class organization to perform at the highest levels.The Cohere IT team is currently seeking an Information Systems Specialist to be part of the day-to-day frontline that provides, supports, and maintains the availability of services and infrastructure within the company’s corporate environment.Desktop Support Technicians are responsible for learning, maintaining, and documenting information pertaining to systems, software, applications, and processes used across the organization. All internal support requests are their responsibility to respond to or escalate to Systems Administrators, as necessary.Last but not least: The ideal candidate will thrive in a fast-paced startup with the ability to wear many hats while prioritizing customer focus. People who succeed here are empathetic teammates who are candid, kind, caring, and embody our core values and principles . We believe that diverse, inclusive teams make the most impactful work. Cohere is deeply invested in ensuring that we have a supportive, growth-oriented environment that works for everyone. What you'll do: Work within Cohere’s established standards, procedures and guidelines in delivering service to staff Fulfill service requests in a highly customer-service oriented manner Monitor, respond to, and escalate service issues in a timely manner

What you'll do Run human-subjects recording sessions end-to-end: participant prep and fitting, sensor configuration and calibration, stimulus delivery, real-time signal monitoring, and session documentation. Own daily system QC for a one-of-a-kind sensing instrument: baseline noise recordings, per-sensor health checks, log review, and escalation of anomalies before they touch a dataset. Own participant operations: recruitment coordination, scheduling, screening, consent, and compliant handling of participant records. Stand up and maintain the operational backbone of the program: SOPs for acquisition, QC, and participant workflows — documentation that survives you. Handle first-pass data operations: file conversion, organization, metadata, and quality review in Python. Partner daily with the program lead to refine acquisition protocols and improve system performance over time. What we're looking for Hands-on experience acquiring physiological or imaging data from human participants in a clinical or research setting Obsessive consistency and attention to detail: you notice when something is off and you don't let it slide. Professional, patient, and calm with research participants — sessions succeed or fail on how people feel in the room. Basic scripting ability (Python and/or shell) for QC and data-handling tasks, or clear aptitude and motivation to build it. High ownership of the unglamorous parts: scheduling, documentation, tidy data hygiene. Discretion — parts of this program are not yet public. We'll walk you through the specifics, including the exact technology you'd be operating, in the first conversation. Useful experience Controlled or low-noise recording environments and highly sensitive instrumentation. Physiological signal-processing tools in Python. Human-subjects research administration (IRB protocols, consent workflows). Research studies involving structured tasks or sensory protocols with human participants.

Position Summary Pfizer is seeking a highly motivated Scientist to join the In Vivo Pharmacology group within the Oncology Research Unit, with a focus on antibody-drug conjugate (ADC) programs. This role supports the execution of high-quality in vivo efficacy, pharmacodynamic, tolerability, and mechanistic studies that enable preclinical ADC discovery and development. The ideal candidate will demonstrate strong technical capability in oncology animal models, careful attention to study details, and a commitment to animal welfare, compliance, and scientific rigor. The Scientist is expected to contribute as a reliable technical and scientific team member while developing increasing independence in study execution, data interpretation, and cross-functional collaboration. Position Responsibilities Execute in vivo oncology studies supporting ADC discovery programs using a variety of in vivo models including syngeneic, cell line-derived, and patient-derived xenograft models as appropriate. Perform routine and advanced in vivo procedures, including tumor measurements, body weight monitoring, test article administration, clinical observations, and sample collection. Support ADC pharmacology studies assessing efficacy, tolerability, pharmacodynamic biomarkers, dose-response relationships, schedule optimization, and combination strategies. Prepare, review, and follow study protocols, dosing schedules, randomization plans, and sample collection timelines in alignment with project goals and internal standards. Maintain accurate, timely, and compliant study records using electronic data capture systems and approved documentation practices. Coordinate with project line leads, vivarium operations, pathology, toxicology translational scientists, bioanalytical, pharmacodynamic and pharmacokinetic teams, and external partners to enable efficient study execution. Assist with data quality revie

We anticipate the application window for this opening will close on - 30 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72&#43; million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life 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. This role will require 75% of travel to enhance collaboration and ensure successful completion of projects. In this exciting role as a Principal Field Clinical Specialist, you will provide day-to-day field clinical study support, technical and education support, and site management, coordination and training for the Mitral and Tricuspid Therapies clinical programs. This role will promote clinical programs through education of current and new investigators, new technologies and case support to achieve safe patient outcomes and company objectives . The M&T Structural Heart Business is one of the fastest growing businesses in the medical device industry and expanding rapidly to serve patients globally. The Structural Heart and Aortic integrated operating unit offers <

We anticipate the application window for this opening will close on - 30 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72&#43; million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life 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. This role will require 75% of travel to enhance collaboration and ensure successful completion of projects. In this exciting role as a Principal Field Clinical Specialist, you will provide day-to-day field clinical study support, technical and education support, and site management, coordination and training for the Mitral and Tricuspid Therapies clinical programs. This role will promote clinical programs through education of current and new investigators, new technologies and case support to achieve safe patient outcomes and company objectives . The M&T Structural Heart Business is one of the fastest growing businesses in the medical device industry and expanding rapidly to serve patients globally. The Structural Heart and Aortic integrated operating unit offers <

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description This role will be based out of our Parsippany, NJ location OR Foster City, California. Job Summary: We are seeking a Clinical Trials Manager (CTM) to support the Oncology pipeline. The CTM drives end-to-end operational delivery of Phase II and III oncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight. This role serves as a key contributor for study execution and study management by coordinating with the internal teams and external partners (including CROs and vendors), and ensuring alignment across all stakeholders to achieve study objectives. The CTM applies strong project management, clinical, and regulatory

Job Title Senior Clinical Development Scientist, Ultrasound &EI Job Description In this role, you have the opportunity to Be a member of the medical and clinical affairs team in Greater China. Medical and Clinical affairs team is an integral part of global Chief Medical Office. The Clinical Development Scientist is responsible for executing evidence-generation processes, clinical development and market access strategies for New Product Introduction (NPI) projects and post-market activities. The role is responsible for analyzing clinical trial protocols and studies, ensuring alignment with regulatory standards and business objectives, and contributes to the study designs. The role drafts comprehensive Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and regulatory submissions, ensuring accuracy and compliance with regulatory requirements. The role maintains data integrity and accuracy throughout studies and performs rigorous literature searches and critical reviews to support evidence-generation processes, providing insights for strategic decision-making. You are responsible for Assesses clinical trial protocols and studies, ensuring alignment with regulatory standards and business objectives, and contributing to the development and refinement of study designs as needed, working under direct supervision. Executes clinical development and market access strategies for assigned New Product Introduction (NPI) projects and post-market activities, integrating inputs from stakeholders such as Marketing/BU Claims, regional/market needs, Health Economics, Market Access, and Post Market Surveillance (PMS). Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing meticulous attention to detail and adherence to regulatory standards.<

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description RESPONSIBILITIES: Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products. Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines. Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries. Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance. Manages the clinical development component(s) in the prepar

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS; Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan; Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts; Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) Create electronic submission packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision. Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges; Serve as point of contact (POC) of programming with statisticians for statistical input and analysis interpretation; Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiatives. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams; Review draft and final production deliverables for project to ensure quality and consistency. Work with global team or sponsors to coordinate project deliverables, timelines and resources. Skills and Responsibilities: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Expert level in applying concept in Artificial Intelligence and Machine Learning in real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical tria

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. Proficient in analyze information and develop innovative solutions to programming and data analysis challenges; Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiative. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. Review draft and final production deliverables for project to ensure quality and consistency. Skills and Qualifications: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 4+ years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. Good understa

Job Title Medical Safety Manager - Ultrasound Job Description Medical Safety Manager, Ultrasound The Medical Safety Manager independently oversees safety surveillance activities for medical products by analyzing data from post-marketing surveillance, literature reviews, and real-world evidence to identify risks and ensure patient well-being. The role supports regulatory compliance through the preparation of safety-related documentation, including Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports. Your role: Independently conducts comprehensive safety evaluations using data from post-marketing surveillance, literature reviews, and clinical trials to proactively identify and assess potential risks and safety signals. Provides critical safety insights and recommendations for risk management activities, including Health Hazard Evaluations, Risk-Benefit Analyses, and recall procedures, ensuring robust patient safety measures are in place. Supports New Product Introduction, clinical studies, and post-marketing efforts by delivering safety-related perspectives and collaborating on safety inputs for regulatory submissions and key documentation such as RBAs, protocols, Clinical Study Reports, and Clinical Evaluation Reports. Responds to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust through transparent communication and supporting the implementation of safety policies, procedures, and programs to promote a culture of compliance. Stays current with evolving medical product safety regulations and guidelines, offering input into the design and execution of safety studies and vigilance activities to ensure adherence to requirements throughout the product lifecycle. You're the right fit if: You’ve acquired 5&#43

Job Title Medical Safety Manager, Hospital Patient Monitoring Job Description Medical Safety Manager, HPM The Medical Safety Manager, Hospital Patient Monitoring is responsible for conducting comprehensive evaluations of safety information sourced form a variety of channels such as Post-Marketing Surveillance (PMS) and literature searches, working under limited supervision. Your role: Provides essential support in bolstering patient safety by actively contributing insights and recommendations to critical processes such as Risk Management, Health Hazard Evaluations (HHE), Risk-Benefit analyses, and recall procedures. Offers valuable assistance in delivering safety-related perspectives for New Product Introduction (NPI) projects, clinical studies, and Post-Marketing Surveillance (PMS) efforts, facilitating informed decision-making. Collaborates effectively to furnish pertinent safety inputs for regulatory submissions and key documents such as Risk-Benefit Analyses (RBA), protocols, Clinical Study Reports (CSR), and Clinical Evaluation Reports (CERs), ensuring compliance and transparency in safety evaluations. Conducts literature reviews and surveillance activities to identify emerging safety issues, ensuring proactive identification and mitigation of potential risks. Provides answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust and transparency in communication regarding product safety. Contributes to the implementation of safety-related policies, procedures, and programs to promote a culture of safety and compliance within the organization. Maintains awareness of evolving regulations and guidelines related to medical product safety and ensures compliance with applicable requirements. Provides input into the design and conduct of safety studies and medical device vigil

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we're changing the way patients are diagnosed and treated for any disorder that affects brain physiology. What you will be doing: Beacon Biosignals is on a mission to revolutionize precision medicine for the brain. We are the leading at-home EEG platform supporting clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our FDA 510(k)-cleared Dreem EEG headband and AI algorithms enable quantitative biomarker discovery and implementation. Beacon’s Clinico-EEG database contains EEG data from nearly 100,000 patients, and our cloud-native analytics platform powers large-scale RWD/RWE retrospective and predictive studies. Beacon Biosignals is changing the way that patients are treated for any disorder that affects brain physiology. The Sleep Study Support Specialist will work within the SleepView Direct department and report to the Manager, Services. This is a second-shift position that is primarily work-from-home, with occasional on-site meetings as needed. The Sleep Study Support Specialist plays an important role in delivering a positive patient and customer experience by providing timely, accurate, and compassionate support throughout the sleep testing process. This position requires strong communication skills, attention to detail, sound judgment, and the ability to effectively manage multiple priorities while working both independently and as part of a cross-functional team. What success lo

ROLE SUMMARY Exciting opportunity in Clinical Pharmacology! Our Clinical Pharmacology Team is looking for an Associate Director to support the exciting portfolio in Internal Medicine. Our team members champion the innovative use of MIDD for efficient drug development and robust decision-making. A great environment for learning and professional growth! Our Clinical Pharmacology Leads have key roles to play in influencing the discovery and development of drugs. Pfizer is a leader in model informed drug discovery and development (MIDD), and we are expanding in influence and impact. We have an open position as Clinical Pharmacology Lead supporting our End-to-End Internal Medicine portfolio. The ideal candidate is responsible for providing the clinical pharmacology and MIDD components of clinical plans and provide clinical pharmacology expertise to the project team and regulatory interactions. Working with multifunctional study team, Clinical Pharmacology Leads utilize innovative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and diseases for rational development strategies and decisions, as well as optimal study designs and dosage regimen selections. ROLE RESPONSIBILITIES Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team and other multifunctional teams as appropriate. Responsible for providing expertise, leadership, and deliverables of clinical pharmacology for the assigned projects within sphere of influence. Design and execute clinical pharmacology plans and implement clinical pharmacology best practices on project teams. Work closely with other disciplines to ensure that sufficient preclinical PK/PD knowledge exists to underwrite safe human administration and to establish the structure of a predictive model prior to FIH. Responsible for planning and overseeing clinical pharmacolo