Clinical Research

• The Clinical Genomics Scientist II analyzes clinical genetics data, curates variants and genes, and summarizes findings for clinical reports.
• Assist laboratory directors and R&D with validation of cutting-edge technologies and software platforms.
• Curation (50%): curation of variants, genes, and gene-disease correlation following ACMG guidelines.
• Analysis (30%): analyzing clinical genomics data, selecting variants for curation/confirmation, variant nomenclature following HGVS guidelines.
• Other (20%): may involve clinical report drafting, test validation, process refinement, presenting findings, monitoring test turnaround time and task delegation.

Clinical Genomic Scientist II – WGS Analysis

• Lead and oversee the curation of variants, genes, and gene-disease correlations following ACMG guidelines
• Perform comprehensive analysis of clinical genomics data involving various techniques such as next-generation sequencing, Sanger sequencing, metabolomics, and chromosomal microarray
• Draft clinical reports, manage validation processes, refine methodologies, and present findings in meetings
• Provide mentorship, guidance, and training to junior team members

Clinical Genomic Scientist – Clinical Indication

• The Clinical Genomics Scientist II analyzes clinical genetics data, curates variants and genes, and summarizes findings for clinical reports.
• Our scientists assist laboratory directors and R&D with validation of cutting-edge technologies and software platforms.
• Curation (50%): curation of variants, genes, and gene-disease correlation following ACMG guidelines.
• Analysis (30%): analyzing clinical genomics data, selecting variants for curation/confirmation, variant nomenclature following HGVS guidelines.
• Other (20%): may involve clinical report drafting, test validation, process refinement, presenting findings, monitoring test turnaround time and task delegation.

Clinical Genomic Scientist II – Clinical Indication

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
• Oversees site interactions post activation through site closeout
• This may include patient recruitment, investigator payments or other related activities
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
• Participates and presents in key meetings such as Kick Off Meeting
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines
• Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed
• Ensures access and audit trail reviews are conducted as required
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools
• Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan
• Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan
• Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity
• Document requested revisions and approvals in CTMS
• Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements
• Provides solutions for obstacles in protocol execution and site management
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations
• Supports Inspection Readiness for clinical trial management scope
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks
• Develop and support execution of corrective action plans at site and study level
• Supports and completes activities to achieve data cut and lock deadlines
• Provides feedback to line managers on staff performance including strengths as well as areas for development
• May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects
• May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation

Clinical Trial Manager

• Receive and prepare specimens according to standard protocols
• Perform laboratory tests and calculations to provide data for use in diagnosis and treatment of disease
• Perform quality control procedures and evaluate test performance and results
• Calibrate, maintain and monitor equipment used in analytical determinations
• Perform phlebotomy procedures as appropriate

Clinical Laboratory Scientist – New Grad

• Devising the clinical pharmacology and model informed drug development strategy via application of quantitative methods to integrate knowledge of nonclinical data (e.g., metabolism, BCS classification, pharmacology, safety), PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape, and drug interactions to influence go/no go decisions, support sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.
• Translate quantitative knowledge into strategic opportunities to influence development along the model-informed drug development principles.
• Planning and performing, or providing oversight, for appropriate analyses (e.g., non-compartmental, population and/or modelling and simulation analysis of PK and/or PD data) of preclinical-clinical translation and dose/exposure-response relationships, to guide dose regimen and optimize study design.
• Planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.
• Planning and delivery of scientifically robust and efficient clinical pharmacology strategies for development candidates.
• Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
• Planning, conducting, and/or providing oversight of PK and PK/PD analyses and reporting.
• Devising clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternate modeling approaches, consistent with regulatory guidelines.
• Managing and/or supervising elements of CPP studies.
• Developing key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape.
• Defining regulatory strategy for CPP and prepare CP contributions to regulatory documents including IBs, IND’s, briefing books, submission packages, responses to health authority questions, and other regulatory documents.
• Represent CP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
• Participating in the evaluation of potential business development opportunities.
• Contributing to the knowledge of clinical pharmacology, model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modelling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and identify new opportunities for applied scientific and technical advancement within the department.
• Working effectively in team environments, managing CP deliverables in accordance with timelines and overall project goals.

Principal Scientist, Clinical Pharmacology – Pharmacometrics

• Support Program Directors and, at times, Global Project Managers with project and administrative functions under their direction to ensure on-time project execution and compliance.
• Assist with study preparations, study maintenance, and closeout activities.
• Create high-quality meeting minutes and documentation.

Project Coordinator – 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

• Support the Director in overseeing global clinical trial execution, including site activation, enrollment, monitoring, and closeout
• Support the Director in leading cross functional trial team meetings and ensure alignment on key deliverables, timelines, and risk mitigation strategies.
• Manage day-to-day operational activities for assigned studies, ensuring adherence to timelines, budgets, and quality standards
• Drive vendor integration strategies to ensure seamless execution between CRO, central labs, and any specialty service providers.
• Act as the main clinical operations point of contact for assigned study-level tasks, including managing CROs and vendors in collaboration with the Director
• Ensure completeness and inspection-readiness of the trial master file (TMF/eTMF)
• Support the development and maintenance of key operational documents including study manuals, ICFs, tracking tools, and monitoring plans
• Participates in the conduct of audits and support regulatory inspections related to GCP
• Monitor regulatory and GCP compliance across trial activities and support audit/inspection readiness
• Review clinical trial data listings to support identification and resolution of protocol deviations, data trends, and outstanding queries
• Own CRO and vendor oversight by tracking deliverables, proactively identifying risks until issue resolution, and performance metrics in partnership with the Program/Study Lead
• Oversee lab sample management processes, including sample tracking, shipment, reconciliation, and vendor coordination to ensure timely and compliant handling of biological specimens
• Contributes to continuous process improvement and SOP development
• Participate in team meetings, providing clinical operations insights and updates to internal stakeholders

Clinical Trial Manager – Senior

• Design clinical studies and evidence strategies supporting global regulatory submissions
• Act as a scientific and clinical liaison with regulatory bodies and external sites
• Partner cross-functionally with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams
• Author and review clinical and regulatory documentation to support product clearance and commercialization
• Build strong internal and external collaborations and mentor junior scientists

Principal Clinical Scientist

• Collaborate with members of the assigned division research team in the organization, implementation, and completion of clinical research trials
• Create and maintain regulatory documents
• Organize protocol implementation and site initiation visits
• Conduct routine monitoring of clinical studies
• Ensure that research projects are conducted in compliance with federal regulations, institutional/departmental guidelines, and standards of Good Clinical Practice.

Clinical Research Coordinator I, Bilingual – Spanish

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post activation through site closeout.
• This may include patient recruitment, investigator payments or other related activities.
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates and presents in key meetings such as Kick Off Meeting.
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
• This may include accompanying CRA team members to sites for observation or conflict resolution.
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.
• Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed.
• Ensures access and audit trail reviews are conducted as required.
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
• Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.
• Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
• Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.
• Document requested revisions and approvals in CTMS.
• Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.
• Provides solutions for obstacles in protocol execution and site management.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations
• This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA).
• Supports Inspection Readiness for clinical trial management scope.
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
• Develop and support execution of corrective action plans at site and study level.
• Supports and completes activities to achieve data cut and lock deadlines.
• Provides feedback to line managers on staff performance including strengths as well as areas for development.
• May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects
• May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation.

• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan)
• Performs regular and ad-hoc medical review of data listings and data visualization as needed
• Authors medical data queries and reviews query responses
• Partners with Medical Directors for medical data review meetings and safety review meetings
• Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met
• Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management
• Attends and present at Trusted Process meetings

Clinical Scientist, Medical Monitoring – Oncology – Breast

• Works with Medical Director to develop medical plans
• Engages with outside experts/consultants/advisors
• Performs regular and ad-hoc medical review of data listings
• Authors medical data queries
• Partners with Medical Directors for medical data review meetings
• Manages project scope of work
• Collaborates with study team members

Clinical/Medical Scientist – Oncology – Gynecologic Malignancies

• Develop medical plans in collaboration with Medical Director
• Conduct medical reviews of data listings and visualization
• Author and manage medical data queries
• Collaborate with project teams on medical data review
• Attend and present at meetings, including internal and external audits
• Comply with data privacy guidelines and standard operating procedures
• May manage limited number of direct reports

Senior Clinical Scientist – Medical Monitoring, Oncology – Breast

• 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 classification of new variants within established guidelines, by examining laboratory and patient data, and evaluating scientific literature to provide evidence for each variant’s role in disease and/or treatment.
• Support the reclassification of variants.
• Prepare and present both external and internal data to classify variants.
• Work with all departments to ensure the highest quality clinical test results with unparalleled accuracy for all patient samples in a timely manner including the identification and resolution of issues.
• Participate in clinical genomics projects to implement, validate, and test new processes for variant classification.
• Responsible for one or more activities related to the classification of variants such as pipeline improvements, classification procedure, autoclassification, or a project involving multiple teams across the enterprise.
• Maintain familiarity with the field’s concepts, practices, and procedures.
• Conduct other duties delegated or defined by the CLIA lab director.
• Occasionally work a variable schedule, including early mornings, evenings, weekends, and/or holidays.

Lead Clinical Genomics Scientist

• Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors.
• You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
• Participating in the development of study protocols, including study design discussions and sample size calculations.
• Participating in exploratory data analyses to evaluate emerging study trends, support scientific decision-making, and generate insights throughout the course of development.
• Leading and contributing to efficacy analyses and interpretation of primary and secondary endpoints.
• Reviewing CRFs and data review guidelines; developing Statistical Analysis Plans (SAPs), including analysis dataset and TLF specifications.
• Performing statistical analyses and interpreting statistical results.
• Leading study activities when called upon and providing strategic statistical guidance to cross-functional teams.
• Utilizing strong communication skills to present statistical methodology, assumptions, and the implications of decisions in clear, non-technical language.
• Serving as a collaborative team player with a willingness to go the extra distance to meet project goals and timelines.

Principal Biostatistician, R Proficiency

• 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 Research jobs in United States

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Clinical Genomic Scientist II – WGS Analysis

Clinical Genomic Scientist – Clinical Indication

Clinical Genomic Scientist II – Clinical Indication

Clinical Trial Manager

Clinical Laboratory Scientist – New Grad

Principal Scientist, Clinical Pharmacology – Pharmacometrics

Project Coordinator – Clinical Research

Lead Biostatistician, Analytical Validation

Clinical Trial Manager – Senior

Principal Clinical Scientist

Clinical Research Coordinator I, Bilingual – Spanish

Clinical Trial Manager

Clinical Scientist, Medical Monitoring – Oncology – Breast

Clinical/Medical Scientist – Oncology – Gynecologic Malignancies

Senior Clinical Scientist – Medical Monitoring, Oncology – Breast

Staff Biostatistician – Analytical Validation

Lead Clinical Genomics Scientist

Principal Biostatistician, R Proficiency

Clinical Scientist, Manager – Translational Science and Medicine, Immunology

Clinical Scientist – Manager, Translational Science and Medicine – Immunology