Clinical Research

• Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
• Serve as the statistical lead on multiple high-priority project teams.
• Partner with bench scientists, bioinformatics, and product development teams to integrate statistical expertise into project planning and execution.
• Prepare comprehensive protocols and reports for cross-functional collaborators and stakeholders.
• Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA.
• Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity.

Lead Biostatistician, Analytical Validation

• Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
• Serve as the statistical lead on multiple high-priority project teams. Partner with bench scientists, bioinformatics, and product development teams to integrate statistical expertise into project planning and execution.
• Prepare comprehensive protocols and reports for cross-functional collaborators and stakeholders.
• Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA.
• Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity.

Staff Biostatistician – Analytical Validation

• Support the execution of clinical trial protocols of the clinical development plan, ensuring compliance with scientific, organizational, and regulatory standards.
• Support end-to-end delivery of clinical trial protocols, including study design, initiation, medical data monitoring, data dissemination, and closeout activities.
• Co-manage and coordinate trial activities with internal, cross-functional and external (e.g., vendors, clinical sites) partners to ensure timely execution of clinical trials and to ensure the quality and integrity of data is critical to the evaluation of study endpoints.
• Support providing training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
• Support the review, interpretation, and reporting of clinical trial data, assisting with ensuring accuracy and integrity for health authority submissions.
• Contribute to the preparation of documents for reporting clinical trial data (e.g. clinical study reports, patient narratives, investigator brochures, and periodic safety updates).
• Contribute to the medical data monitoring activities in partnership with the Study Responsible Physician, including the evaluation, documentation, and reporting of ongoing clinical trial data per defined medical data review plan.
• Contribute to process improvements and implementation of best practices in clinical trial execution.
• Collaborate with cross-functional partners to support clinical strategies with overall product development goals.
• Contribute to the preparation and presentation of the results of clinical research in internal department/ management meetings.
• May also support the preparation of materials for external expert engagements.
• Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO).

Clinical Scientist, Manager – Translational Science and Medicine, Immunology

• Support the execution of clinical trial protocols of the clinical development plan, ensuring compliance with scientific, organizational, and regulatory standards.
• Support end-to-end delivery of clinical trial protocols, including study design, initiation, medical data monitoring, data dissemination, and closeout activities.
• Co-manage and coordinate trial activities with internal, cross-functional and external (e.g., vendors, clinical sites) partners to ensure timely execution of clinical trials and to ensure the quality and integrity of data is critical to the evaluation of study endpoints.
• Support providing training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
• Support the review, interpretation, and reporting of clinical trial data, assisting with ensuring accuracy and integrity for health authority submissions.
• Contribute to the preparation of documents for reporting clinical trial data (e.g. clinical study reports, patient narratives, investigator brochures, and periodic safety updates).
• Contribute to the medical data monitoring activities in partnership with the Study Responsible Physician, including the evaluation, documentation, and reporting of ongoing clinical trial data per defined medical data review plan.
• Contribute to process improvements and implementation of best practices in clinical trial execution.
• Collaborate with cross-functional partners to support clinical strategies with overall product development goals.
• Contributes to the preparation and presentation of the results of clinical research in internal department/ management meetings.
• May also support the preparation of materials for external expert engagements.
• Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO).

Clinical Scientist – Manager, Translational Science and Medicine – Immunology

• Join our Clinical Surveillance & Training (CST) team as a Clinical Scientist, where you will play a critical role in ensuring endpoint quality, data integrity, and trial success across global clinical programs
• Design and deliver scientifically grounded rater training programs to ensure consistent, high-quality endpoint assessment and reduce variability across sites
• Perform comprehensive eligibility reviews, providing a second level of scientific oversight to confirm appropriate patient selection and minimize protocol deviations and safety risks
• Analyze clinical and endpoint data to identify trends, variability, and potential risks—translating findings into actionable insights that improve study execution
• Partner with sponsors and study teams to review protocols and provide expert guidance on endpoint strategy, scale selection, and study design feasibility
• Collaborate cross-functionally with clinical operations, medical, and sponsor teams to proactively identify risks and deliver solutions that protect study integrity

Clinical Scientist – Clinical Surveillance & Training, Clinical Psychologist/Neuropsychologist

• Oversight of activities
• Evaluate the intent of the study concept and make informed recommendations based on scientific review
• Effectively communicate with key stakeholders through the initial viability/feasibility concept phase
• Utilize tools (e.g. Medidata, Symphony) to generate data to satisfy feasibility/viability requests
• Author reports to inform project teams of assessments
• Collaborate with cross-functional teams to evaluate study concepts and deliver comprehensive feasibility reports

Senior Manager, Feasibility

• Interpreting diagnostic test results
• Review and summary of relevant medical literature
• Review and summary of clinical information
• Apply variant classification guidelines for assay findings
• Follow report generation protocols to meet requirements for quality and turnaround time
• Attend trainings for the reporting protocols applicable to the specific position or specialty
• Become knowledgeable in the information technology systems needed to perform tasks relevant to the specific position
• Work towards expertise in clinical and technical aspects relevant to the specific position
• Interpret clinical diagnostic testing results in accordance with established SOPs
• Variant assessment and classification
• Independently draft clear, accurate clinical testing result reports

Reporting Clinical Genomics Scientist – HCT

• As a CLS/Clinical Lab Scientist QC lab supervisor on the graveyard shift, you will be responsible for the nightly operations and supervision of the Quality Control lab and QC activity in our Pomona Blood Center.
• You will be responsible for 100% record review of testing and the batch release of test results to the customer.
• You may participate in education and training activities.
• You will supervise the daily review of all initial and repeat testing and quality control records to ensure validity of results prior to the batch release of test results and problem reviews.
• Assist staff in performing reviews as needed.
• Schedule personnel and workflow to efficiently maximize and maintain optimum productivity.​
• Perform supervisory review of documents.
• Ensure monthly product QC requirements are met.
• Ensure quality and quantity of manufacturing and distribution goals are met; including timelines.
• Ensure accurate electronic and physical inventories location for products are maintained.
• Participate in documenting, investigating, troubleshooting and preventing recurrence of department errors, problems and customer concerns/complaints.
• Communicate with Laboratory staff when necessary to resolve problems, facilitate sample shipment, and clarify test data transmission issues.
• Participate in process improvements within area of responsibility.
• Lead suspect product/sample management process.
• May participate in the validation of hardware, software, instrumentation, test kits, and procedures as directed.
• May perform, review and approve quality control on products, reagents, equipment and various test kits.
• Serve as departmental expert on the applicable computer systems.
• Maintain the required records and files.
• Flexible working on the bench at least 40% of the time.
• Flexible to work weekends when there is short staffing; flexible to stay late to help with unexpected operational demand, respond to staff's urgent needs on off hours, as needed.
• Participate in discrepancy resolution of unusual or unexpected results.
• Ensure action taken in the case of an invalid or suspect test is in compliance with applicable policies, procedures, and regulations.
• Identify and prepare initial documentation for run problems and error reports.
• Manage proficiency testing according to applicable procedures and regulations.
• Ensure proficiency samples are tested, results recorded accurately and sent timely, and graded results are reviewed upon receipt.
• Ensure that supervisor and operations management staff is notified promptly of all discrepant or invalid test results discovered during QC review.
• Ensure that all reagents used for testing are in date and show no sign of drift or contamination as indicated in the daily quality control data.

Clinical Laboratory Scientist – CLS Supervisor

• Perform all core Clinical Research Coordinator (CRC) responsibilities for human subjects’ (clinical) research.
• Assisting in assessing feasibility of clinical research protocols.
• Preparing materials needed for regulatory review and submission to the Institutional Review Board (IRB).
• Identifying potential study participants.
• Collecting research data/specimens.
• Completing study records in an accurate and timely manner.
• Participating in quality assurance audits.
• Managing study materials and supplies.
• Communicating across multiple teams.
• Archiving records in accordance with appropriate policies and procedures.
• Development of source documents and/or case report forms.
• Coordination of research/project team meetings.

Clinical Research Coordinator I, Orthopedics

• Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out, including feasibility analysis, development of clinical investigation plans, contracts and budgets, timelines, trial oversight, data quality monitoring, and overall study leadership and decision-making.
• Contribute to clinical research strategy, ensuring alignment with intended indications, evidence generation plans, and applicable FDA and international regulatory requirements.
• Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.
• Provide guidance and lead escalations on complex clinical quality, CRO, or vendor performance issues, advising senior leadership to support sound, well-informed decision-making.
• Partner closely across Science collaborators, Product, Engineering, Regulatory, Quality, Clinical Data Management, Legal, and external partners to align study execution with product, clinical, and regulatory goals.
• Translate study requirements into operational plans, including protocol-related planning, study-specific documentation, training, reporting needs, and core study management tools such as dashboards, trackers, and decision logs.
• Work closely with CROs and data management partners to ensure high-quality and auditable evidence generation across eCRFs, EDC build, data review workflows, data cleaning, and database lock.
• Drive study-level strategic decision-making by proactively identifying emerging risks and challenges, developing scenario plans and contingency options, and proposing innovative solutions to keep trials on track when circumstances change.
• Help strengthen and maintain Oura’s Quality Management System by contributing to SOPs, templates, work instructions, and repeatable study playbooks.
• Identify systemic risks or gaps across the clinical portfolio, not just within a single study, and proactively recommend process changes to leadership.
• Mentor and provide operational guidance to Clinical Trial Managers and Clinical Research Coordinators, supporting colleagues as they navigate escalations, ambiguity, and clinical research feedback.

Senior Clinical Trial Manager

• Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out, including feasibility analysis, development of clinical investigation plans, contracts and budgets, timelines, trial oversight, data quality monitoring, and overall study leadership and decision-making.
• Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.
• Partner closely across Science collaborators, Product, Engineering, Regulatory, Quality, Program, Clinical Data Management, Legal, and external partners to align study execution with product, clinical, and regulatory goals.
• Translate study requirements into operational plans, including protocol-related planning, study-specific documentation, training, reporting needs, and core study management tools such as dashboards, trackers, and decision logs.
• Work closely with CROs and data management partners to ensure high-quality and auditable evidence generation across eCRFs, EDC build, data review workflows, data cleaning, and database lock.
• Drive study-level strategic decision-making by proactively identifying emerging risks and challenges, developing scenario plans and contingency options, and proposing innovative solutions to keep trials on track when circumstances change.
• Help strengthen and maintain Oura’s Quality Management System by contributing to SOPs, templates, work instructions, and repeatable study playbooks.

Clinical Trial Manager

• This position reports to Manger/Sr. Manager, Medical Sciences and requires a strong candidate with expertise in the analysis of medical literature, data from clinical trials and pre-clinical studies, and sound knowledge of applicable regulations and standards.
• The position will mainly focus on the development of Clinical Evaluation Plans (CEPs) & Clinical Evaluation Reports (CERs), with a potential for future additional responsibility in the development of other clinical evidence documents.
• The purpose of this job is to work collaboratively to develop strategies for the creation of CEPs followed by the development of clinical evaluation reports (CERs) per EU MDR, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, re-certification and proposed indication/labeling changes.
• Further, the responsibility includes the development of regular CEP and CER updates to maintain EU product conformance.
• Interact with internal cross-functional teams (engineering, product development, regulatory, post-market surveillance) to define and plan the strategy for the development of CEPs and CERs for new products requiring CE Mark.
• Develop and author clinical documentation for regulatory submissions, mainly key sections of the CEP, and the entire CER document.
• Develop and author responses to the requests and questions on the clinical documentation from the regulatory authority.
• Possess or acquire in-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
• Participate in and/or perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies; stay informed about applicable clinical landscapes and trends.
• Provide product guidance and expertise to the clinical librarian to facilitate conducting literature searches on products/product families.
• Review scientific literature and interpret and summarize published data on risks, alternate therapies and device-specific benefits; collect and summarize primary data to support risk assessment.
• Critically appraise scientific literature and write clinical summaries for products and surgical procedures.
• Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
• Manage CEP/CER timelines required by product development teams and global Regulatory Bodies by utilizing appropriate project management tools.
• Serve as the SME and/or functional representative for R&D development activities (e.g., Product or Technology Development Process teams) and support broader Clinical/Medical Affairs activities such as Regulatory submissions/responses.
• Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.
• Provide clinical perspective and support and guide new product development for CE Mark purposes.
• May require participation in ongoing core team activities (e.g., weekly meetings) or provide periodic participation and input as needed.
• Support the clinical affairs (CA) team with the creation of clinical content for other documents including Investigator brochures, manuscripts, scientific abstracts, conference presentations, and posters based on Intuitive clinical trials.
• Support the CA team with the development and writing of clinical study protocols and Clinical Study Reports (CSRs).
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)

Senior Clinical Scientist

• Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for J&J MedTech Neurovascular;
• Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
• May serve as the primary contact for clinical trial sites (e.g. site management);
• Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
• Ensures applicable trial registration (e.g. on www.clinicaltrials.gov ) from study initiation through posting of results and support publications as needed;
• Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials;
• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
• Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
• Oversees and supports the development and execution of Investigator agreements and trial payments;
• Is responsible for clinical data review to prepare data for statistical analyses and publications;
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
• Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs).

Clinical Research Leader, Neurovascular

• Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
• Oversee/execute feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with ICH-GCP and applicable legislation.
• Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual).
• Manage/oversee ordering, tracking, and accountability of investigational devices and trial materials.
• Lead clinical data review to prepare data for statistical analyses and publications.
• Act as primary contact for clinical trial sites and collaborate with site personnel, IRBs, and contractors/vendors.

• Interpreting diagnostic test results
• Review and summary of relevant medical literature
• Review and summary of clinical information
• Attend trainings for the reporting protocols applicable to the specific position or specialty
• Become knowledgeable in the information technology systems needed to perform tasks relevant to the specific position
• Work towards expertise in clinical and technical aspects relevant to the specific position
• Interpret clinical diagnostic testing results in accordance with established SOPs
• Other duties as assigned

Clinical Genomics Scientist – Clinical Summaries

• Attend trainings for the reporting protocols applicable to the specific position or specialty
• Become knowledgeable in the information technology systems needed to perform tasks relevant to the specific position
• Work towards expertise in clinical and technical aspects relevant to the specific position
• Interpret clinical diagnostic testing results in accordance with established SOPs
• Other duties as assigned

• Own the development and execution of the feasibility strategy in partnership with clinical program team
• Lead the successful delivery of the feasibility process to expedite cycle times
• Manage L5 GFL Direct Reports, overseeing performance reviews, career progression, training, and engagement
• Lead activities pertaining to country and site identification, feasibility and country selection within a clinical study
• Partner with study team members, data analytics teams, and country teams to design and conduct global feasibility activities on time with high quality delivery
• Lead the collection of local internal and external data to define an optimal geographic country footprint and proposed sites for participation in a clinical study
• Synthesize, interpret and integrate data and information to provide clear feasibility recommendations
• Facilitate the study baseline enrollment commitment & change process
• Initiate and lead global feasibility continuous improvement efforts and initiatives
• Support development of systems, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility

Global Feasibility Senior Manager

• As a Clinical Scientist, you will support the Clinical Affairs team in executing clinical programs aligned with Hyperfine’s strategic priorities.
• You will work closely with cross-functional teams including imaging, regulatory, marketing, and external research sites to generate clinical evidence, enable research programs, and translate data into impactful outputs.
• You will be responsible for contributing to clinical study design, supporting study execution, and extracting actionable insights from clinical data to inform publications and business strategy.
• You will collaborate with clinical partners to optimize imaging workflows and enable use cases across hospital, office-based, and international settings.

Clinical Scientist

• Lead end-to-end analytics initiatives from problem framing and experimental design through production delivery
• Architect and implement scalable data solutions
• Fuse disparate data sources and establish data preparation standards
• Implement data quality controls and manage schema changes
• Develop, evaluate, and deploy predictive models and optimization approaches
• Support text-heavy and unstructured-data use cases with NLP methods
• Deliver decision-support products through Power BI
• Provide technical leadership and consultation

Biostatistician

• Acquire, integrate, and prepare data from multiple sources to enable operational reporting, readiness analytics, and decision support.
• Design and implement ETL/ELT pipelines using SQL Server and Databricks leveraging Apache Spark (PySpark) for scalable batch processing and data transformation.
• Develop and maintain curated, analysis-ready datasets (e.g., dimensional models, governed reporting tables) with attention to data quality, lineage, and repeatability.
• Optimize data processing performance (partitioning strategies, efficient joins, job tuning) and contribute to reliable scheduling/orchestration and monitoring of recurring workloads.
• Apply statistical methods, data mining, and machine learning to generate actionable insights, forecasts, and predictive analytics relevant to military missions and readiness.
• Create dashboards and analytical products using Power BI, including semantic modeling and measures to support consistent metrics and reporting.
• Support low-code solutions by integrating data products into Power Apps (Canvas and Model-Driven) and automations using Power Automate.
• Contribute to text and language-focused use cases by preparing and analyzing unstructured data (basic NLP preprocessing, labeling/curation, feature creation).
• Demonstrate familiarity with LLMs and agent concepts (prompting patterns, retrieval-style workflows, evaluation considerations) and assist senior team members in implementing these capabilities where appropriate.
• Document data sources, transformations, assumptions, and analytical methodologies to ensure transparency and operational continuity.

Clinical Research jobs in California

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Lead Biostatistician, Analytical Validation

Staff Biostatistician – Analytical Validation

Clinical Scientist, Manager – Translational Science and Medicine, Immunology

Clinical Scientist – Manager, Translational Science and Medicine – Immunology

Clinical Scientist – Clinical Surveillance & Training, Clinical Psychologist/Neuropsychologist

Senior Manager, Feasibility

Reporting Clinical Genomics Scientist – HCT

Clinical Laboratory Scientist – CLS Supervisor

Clinical Research Coordinator I, Orthopedics

Senior Clinical Trial Manager

Clinical Trial Manager

Senior Clinical Scientist

Clinical Research Leader, Neurovascular

Clinical Research Leader, Neurovascular

Clinical Genomics Scientist – Clinical Summaries

Clinical Genomics Scientist – Clinical Summaries

Global Feasibility Senior Manager

Clinical Scientist

Biostatistician

Junior Biostatistician