Clinical Study Operations Associate in United States

ROLE SUMMARY The primary purpose of this job role is to function as a member of the Sample Logistics (SL) operations within Pfizer Vaccine Research and Development (VRD). The incumbent will be responsible for receiving samples from global clinical/study trials according to approved protocols and processes. The individual will participate in all aspects of tracking and documenting the chain of custody of samples. The incumbent’s role will include sample receipt, documentation, storage, tracking, aliquoting, distribution to the testing labs, and sample disposal. The colleague will work in a team setting and will share roles and responsibilities as assigned by the team leader/manager. ROLE RESPONSIBILITIES The incumbent will be required to complete all processes as detailed in Sample Management’s Standard Operating Procedures. The colleague will perform job responsibilities in compliance with GXP and all other regulatory agency requirements. The candidate will receive samples from clinical trial sites and enter samples into an electronic database management system. Performs sample storage and retrieval using manual freezers and BiOS (automated freezer storage system). Performs manual sample aliquoting and aliquoting using the Hamilton robotic instrument. Ship samples and lab supplies to external and internal testing labs. Assists in the general maintenance of the Hamilton robotic instruments. Participates in the shipment discrepancy resolution process. Completes documentation according to cGMP/GLP and all other regulatory agency requirements and archives documents as per applicable policies. Carries out sample disposal/sample destruction according to regulated policies and procedures Performs other duties as assigned. QUALIFICATIONS Must Have Bachelor of Science Degree or Bachel

ROLE SUMMARY The primary purpose of this job role is to function as a member of the Sample Logistics (SL) operations within Pfizer Vaccine Research and Development (VRD). The incumbent will be responsible for receiving samples from global clinical/study trials according to approved protocols and processes. The individual will participate in all aspects of tracking and documenting the chain of custody of samples. The incumbent’s role will include sample receipt, documentation, storage, tracking, aliquoting, distribution to the testing labs, and sample disposal. The colleague will work in a team setting and will share roles and responsibilities as assigned by the team leader/manager. ROLE RESPONSIBILITIES The incumbent will be required to complete all processes as detailed in Sample Management’s Standard Operating Procedures. The colleague will perform job responsibilities in compliance with GXP and all other regulatory agency requirements. The candidate will receive samples from clinical trial sites and enter samples into an electronic database management system. Performs sample storage and retrieval using manual freezers and BiOS (automated freezer storage system). Performs manual sample aliquoting and aliquoting using the Hamilton robotic instrument. <span style="color:#

POSITION SUMMARY You will be responsible for managing the clinical sample logistics function for Pfizer’s vaccine clinical portfolio, ensuring samples are transported safely, compliantly, and reliably across domestic and international clinical trial networks to the Pearl River, NY biorepository and then distributed to our network of internal and external testing laboratories. You will lead an end-to-end logistics strategy from study start-up through operations and finally sample disposition. Your responsibilities include leading a large team, improving global logistics capabilities, advancing digital and automation initiatives, and partnering with Vaccines, Quality, Legal, Finance, Compliance, clinical study teams, couriers, and technology vendors. You will be accountable for maintaining sample integrity, enabling global clinical trial execution, and developing scalable logistics processes to support Pfizer’s vaccine pipeline. KEY RESPONSIBILITIES Lead the global sample logistics function--Provide strategic and operational leadership for a team of 40&#43; colleagues responsible for domestic and international shipment execution, study start-up support, ongoing operations, and clinical sample lifecycle management. Shape long-term sample logistics strategy. Develop scalable operating models, governance frameworks, and business continuity plans that support pipeline growth, clinical trial expansion, and evolving global regulatory expectations. Protect sample integrity and compliance. Ensure reliable, temperature-controlled movement of clinical biological samples while maintaining adherence to applicable FDA, EMA, IATA, DOT, CDC, trade compliance, GCLP, and Pfizer quality requirements. Advance inspection readiness and quality oversight. Maintain robust documentation and audit-ready processes for deviation management, CAPAs, change controls, an

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

Why Patients Need You Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world. What You Will Achieve As part of the Comparative Medicine team, you will support the Research & Development site by managing a vivarium to deliver flawless animal care and welfare and will assure the quality of care and the animal facility environment is in compliance with local regulations and AAALAC International guidelines partnering with Research and Development Research Units and Partner lines to facilitate study support. It is your hard work along with innovative ideas and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Assure that the care and welfare of laboratory animals is provided in compliance with local regulations and AAALAC International guidelines. Manage and engage animal care and technical staff in the pursuit of flawless animal care and welfare by ensuring adherence to established policies and procedures. Support the career and personal development of the animal care and technical staff. Assist with a centralized CM training program for research animal care and use for animal care staff, principal investigators and research technicians throughout WRD. Participate in the direction of a centralized CM program of occup

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

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

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 The Clinician Medical Monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. In addition to study level activities, the clinician medical monitor may participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and aid new business development on market opportunities and the target product profile. ROLE RESPONSIBILITIES Accountable for safety across the study Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the “Safety Data Review Guide – for Clinicians.” Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context required for benefit-risk assessm

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