Job Search Results for clinical

Sr. Clinical Trial Manager

Insight Global is looking for a Senior Clinical Trial Manager to provide strategic and operational leadership to Clinical Trial Managers and associated study staff in support of global clinical... More programs. This role is accountable for the planning, execution, and oversight of RDN clinical trials, ensuring alignment with program strategy, timelines, budgets, quality standards, and regulatory requirements. The Senior Manager drives clinical excellence across studies, oversees vendor performance, and ensures audit readiness throughout the lifecycle of each trial. This role leads and develops Clinical Trial Managers and assigned study personnel while overseeing the end-to-end operational execution of global clinical trials in compliance with protocols, GCP, SOPs, and regulatory requirements. The individual translates program strategy into operational plans, timelines, and resource needs, ensuring cross-functional alignment and on-time delivery of study milestones. Responsibilities include oversight of study documentation, systems, and regulatory submissions; management of CROs and external vendors including performance, issue escalation, and budgets; and proactive risk identification and mitigation. The role provides clear, data-driven updates and recommendations to clinical leadership, maintains financial oversight of clinical trial budgets, builds strong relationships with investigators and clinical sites to support enrollment, ensures inspection readiness, and drives continuous improvement across clinical operations processes and best practices. Pay range: $70-$90We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Clinical Application Specialist

Job Description:The NC HIEA Application Specialist will lead technical assistance efforts by working closely with NC HIEA participants and their electronic health record (EHR) vendors to implement,... More improve, and maintain data integrations. This role supports NC HealthConnex data exchange services, including the provider clinical portal, by ensuring system reliability, performance, and data accuracy. This role will support the Chickasaw Behavioral Health Information Technology Pilot Program for North Carolina. Key responsibilities include coordinating testing and deployments, supporting technical analysis efforts, and collaborating with cross-functional teams such as participants, EHR vendors, data architects, developers, analysts, and clinical stakeholders. The Application Specialist will ensure data quality, system reliability, and effective communication across teams, while serving as a primary point of contact for project updates, metrics, status reporting, and technical support.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Clinical Research Specialist

A large medical device company in Irvine, CA is looking for a HYBRID Clinical Research Specialist. This candidate will play a crucial role in supporting a 10 year post market clinical trial for... More breast implants. Their key responsibilities will include monitoring clinical studies, data verification, regulatory compliance, study documentation, site visits and coordination, and developing written travel reports.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

REMOTE Clinical Project Manager

We are seeing an experienced Program Manager to manage clinical projects in the Cerner & Athena space. This role requires someone who can dive into the details while maintaining strategic oversight,... More ensuring a seamless clinical and financial implementation.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Senior Clinical Trial Leader

One of our large Life Sciences clients is looking for a Senior Clinical Trial Leader to help support a medical device cardiovascular clinical trial . This individual will manage day-to-day operations... More of said clinical trials, including budgets and oversight of Clinical Research Associates (CRAs) and other operational team members. They will collaborate with cross-functional partners to ensure smooth execution of trials and oversee Trial Master Files (TMFs), payments, and ensure all documentation is cleaned up and organized. They will ensure adherence to IDE regulations, focusing on patient safety and regulatory compliance and prepare comprehensive reports and updates for stakeholders.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Senior Clinical Statistical Programmer

Data Standards & Harmonization? Lead end-to-end mapping and transformation of SDTM domains? Ensure compliance with: ? CDISC SDTM standards? Sponsor-specific controlled terminology and structure?... More Perform consistency checks against previously harmonized datasets? Support harmonized datasets for integrated analysis readinessADaM Dataset Creation? Develop ADaM datasets (using Admiral R package) based on: ? Statistical Analysis Plan (SAP)? Analysis specifications? Ensure traceability between SDTM and ADaM? Implement: ? Derived variables? Population flags? Analysis endpointsRegulatory-Ready Documentation & DeliverablesPrepare submission-ready outputs aligned with FDA/EMA expectations, including:? SDTM & ADaM datasets (with define.xml)? Dataset-level and analysis-level documentation? Example outputs and sample displays? Integrated Case Report Forms (iCRFs)? Reviewer documentation: ? Clinical Study Reviewer?s Guide (cSDRG)? ADaM Reviewer?s Guide (aDRG)? Variable derivation documentation and codelist mappings? Annotated CRFsSAS Programming & Integrated Outputs? Write production-level SAS programs, including: ? Source-to-target mapping macros/scripts? Validation checks? Reusable code modules? Create integrated clinical study reports? Produce Integrated Clinical Study DRG (iCSDRG) documentation? Populate iSDRGs from SAS outputs? Ensure: ? Independent review readiness? Good programming practices (GPP)? Data quality and reproducibilityQuality Control & Collaboration? Perform QC/validation using Pinnacle 21 on: ? Harmonized Sponsor Study SDTMs? Overall Harmonized SDTMs? Resolve validation discrepancies across studies? Partner cross-functionally to: ? Address data issues? Clarify specifications? Maintain: ? Detailed documentation? Version control? Audit trails? Participate in regular project check-insWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Clinical Project Planner

Insight Global is looking to hire 4 Clinical Project Planners for a large pharma client. In this role, the Clinical Project Planner will support the Project and Portfolio Management team by helping... More drive the day-to-day planning and execution of clinical studies during the transition from MS Project to Planisware. This individual will work closely with cross-functional stakeholders to build, maintain, and update detailed clinical study plans, timelines, schedules, and roadmaps within Planisware, while leveraging MS Project as needed. They will ensure study plans are accurate, aligned, and up to date, proactively identifying dependencies, risks, and timeline impacts. The planner will regularly communicate with project managers and clinical trial teams to coordinate activities, support planning discussions, and ensure consistency across studies. Success in this role requires strong technical proficiency in Planisware, a solid foundation in clinical trial planning within pharma, and the ability to clearly communicate and collaborate in a fast-paced, remote environment. This is a 6-month contract operating on EST hours at a pay rate of $50/hr.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Clinical Research Scientist

One of our large MedTech clients is looking for a Clinical Research Scientist to join their team for a 12+ month project. This individual will support multiple class 3 device trials. They will... More develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal supervision, plan for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures. They will partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables and will be responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and core teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP). This role will entail developing strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders and drafting study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Senior Manager of Clinical Strategy

- Clinical Strategy & Protocol Developmento Lead the development of IRB and clinical study protocols in alignment with company objectives.o Collaborate with surgeons and clinical advisors to design... More impactful studies that address business and clinical needs.o Participate in the overall clinical strategy planning process, including statistical analysis plans and protocol review cycles.o Submit and manage regulatory applications (FDA and other global agencies).- Clinical Execution & Oversighto Oversee clinical study activities including site selection, investigator engagement, initiation, monitoring, and study closeout.o Ensure studies are conducted in compliance with approved protocols, regulatory standards, and timelines.o Perform site visits, oversee test article reconciliation and disposition, and maintain accurate documentation.- Data Integrity & Reportingo Ensure the accurate transmission and validation of clinical data to data management centers.o Resolve case report discrepancies and ensure completeness and integrity of clinical records.o Author or support the development of clinical study reports, white papers, and regulatory submissions.- Scientific Communication & Publicationo Develop and contribute to scientific manuscripts, conference presentations, and publications.o Provide clinical evidence to support marketing claims and product positioning.- Cross-Functional Collaborationo Work closely with product management, engineering, regulatory, and medical affairs to ensure alignment between product development and clinical evidence.o Identify clinical evidence gaps across the product portfolio and recommend solutions.- Leadership & Innovationo Guide cross-functional teams in the generation of robust clinical evidence.Maintain awareness of evolving industry trends, research methodologies, and regulatory changesWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Vice President of Clinical Services

Role OverviewSenior, standalone role leading clinical strategy and program developmentOwns clinical storytelling: defining programs, outcomes, KPIs, and impactHeavy external-facing component?selling... More value to pharma partnersNo direct reports; highly collaborative with operations and cross-functional leadersRequires strong executive presence, influence, and outcomes-driven mindsetKey ResponsibilitiesBuild and lead clinical strategy across mental health?focused programsDesign and measure KPIs that demonstrate clinical and business impactPartner with operations and internal leaders to execute programsTranslate clinical outcomes into compelling value propositions for pharmaDrive results without a formal teamIdeal Backgrounds / TitlesValue-Based Solutions leadershipClinical Pharmacist background strongly preferredDirector of Clinical PharmacyPharmacist in ChargeRegional Pharmacy ManagerGlobal Market Access experience a plusHealth systems + behavioral health experience is a major plusWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less