Job Search Results for clinical

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

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

Remote Clinical Research AR Specialist

Our client is looking for a Remote AR Specialist to help with an unpaid invoicing backlog. This person can sit anywhere and work any hours as long as they are productive. This is a 40 hour a week... More project for 2-3 months. Our ideal candidate is someone who has clinical research experience or B2B collections. Other responsibilities include: ?Contact sponsors regarding aging invoices, payment remittance details and payment status.?Prepare invoices for patient visits and procedures for assigned locations. ?Reconcile all payments and maintain accurate aging of Accounts Receivable.?Recognize issues that may arise when processing or performing all tasks assigned and report such issues to the manager. ?Perform an audit to ensure that all payments, or charges, are in balance or takes the appropriate action. Appropriate action includes communication with manager or controller. ?Respond to basic Accounts Receivable process/billing questions posed by various internal/external parties in a timely and knowledgeable manner.?Other duties may be assigned at any time.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 Analytics Program Manager

An employer in the Orange County area is seeking a Clinical Analytics Program Manager. This is a contract to hire role, can sit anywhere in CA with expectation to come on site quarterly. This is a... More hands-on, senior analytics role responsible for leading advanced statistical analysis, predictive modeling, and organizational analytics in a healthcare behavioral health setting. The role combines individual contributor statistical work with consultative leadership, partnering closely with clinical, research, and IT teams to turn complex data into actionable insights. The position supports both ongoing organizational analytics and research driven initiatives, including authorship on publications, consultation on study design, and limited grant related work. While this role provides mentorship and guidance to others, it is a deeply hands-on in data analysis and modeling. The role will focus on two primary areas, the first being consultation & organizational analytics. They will serve as a consultative analytics partner to clinical, research, and organizational leaders, supporting ongoing organizational, clinical, and research analytics, including operational performance, outcomes analysis, and population-level trends. They will funnel data from enterprise systems and data warehouses into usable analytical frameworks. Second, providing predictive modeling. This includes hands on statistical analysis, including descriptive and inferential statistics, regression modeling (linear, logistic, poisson, multinomial), and predictive modeling at an organizational level. They will develop and maintain predictive models related to client profile analysis (age, performance, clinical characteristics, and dosage optimization models). They will partner with IT and clinical stakeholders to set up data structures, then independently conduct analyses and deliver outputs.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 System Support Specialist

Insight Global is seeking an RTSM (Randomization & Trial Supply Management) Support Specialist to provide technical and operational support for RTSM systems used in clinical trials. This role focuses... More on troubleshooting issues, resolving system tickets, and ensuring seamless support for clinical sites and study teams.Key Responsibilities? Monitor and manage incoming tickets (ServiceNow or similar systems) related to RTSM platforms? Troubleshoot and resolve issues such as: ? User access and permissions? System functionality errors? Study configuration-related inquiries? Act as the first line of support for clinical sites and study teams? Resolve approximately 80% of issues independently; escalate complex issues to PMs or technical teams? Communicate with stakeholders (e.g., clinical sites, study teams) via email or system updates? Maintain accurate documentation of issues, resolutions, and escalations? Support ongoing system operations across active clinical trialsThis individual must reside in EST.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 Systems Analyst

Insight Global is looking for a candidate to join our LIS consulting client to support their clients implementations as a fulltime employee. The candidate should have two years of experience working... More with Laboratory information systems and come from a medical technologist background. This candidate will take on structured and regimented implementations. You will work with the end users to troubleshoot, diagnose and correct problems related to the LIS. The candidate will be a part of performing system customizations including development of alerts/hard stops. Data integrations, order generation and automations. This person will be working directly under the Chief Services Officer. Up to 25% travel may be required with the expectation of being on call one week out of the month. This position is full time and looking to start ASAP.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 Documentation Improvement (CDI) Specialist

Insight Global is seeking a fully remote Clinical Documentation Improvement (CDI) Specialist to support a Healthcare AI client. This is a part-time opportunity working approximately 10?20 hours/week... More where candidates will leverage their CDI expertise to evaluate, validate, and improve AI-driven documentation improvement strategies. This role is highly analytical and requires a strong understanding of inpatient documentation, DRG methodologies, and compliant query practices. Laptop and equipment will be provided.Shift Times: Flexible scheduling within Monday-Friday, 9am-8pm PST (can't work weekends)(must be available 10-20 hours/week from 9am-8pm PST // ideal for individuals seeking additional income)Duration: 3-month contract (potential to extend)Responsibilities:? Review inpatient medical records and evaluate AI-generated CDI recommendations for documentation improvement opportunities? Assess the accuracy, reasoning quality, and compliance of AI-identified CDI queries? Identify gaps where AI recommendations diverge from compliant CDI practices and explain discrepancies? Analyze clinical documentation to identify CC/MCC opportunities, severity of illness (SOI), and risk of mortality (ROM) indicators? Provide detailed clinical reasoning behind documentation improvement opportunities to help enhance AI modeling and outputs? Ensure queries are compliant, non-leading, and appropriately structured to maintain positive provider relationships? Partner with product and GTM teams to critique presentations and provide subject matter expertise on CDI workflows and best practicesWe 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 Team Manager (Nursing)

An employer is hiring a Remote Clinical Team Manager to help lead and develop our client's remote nursing team delivering Chronic Care Management (CCM) and Principal Care Management (PCM) services.... More You will be the right-hand person to the CEO and Clinical Supervisor. Responsibilities:- Lead a remote team of nurses (10-15)- Establish the client's clinical culture and performance- Establish KPIs, workflows, and SOPs from the ground up- Help hire, onboard, and train clinical staff- Own quality assurance across patient interactions- Ensure regulatory and operational compliance- Help shape clinical team budgets as they continue to scaleThis is a remote role, working business hours 9AM-5PM EST (if located in MT/PST, must be okay starting days earlier around 6-7AM PST/MT)Salary: $110,000-$130,000Interview Process: 2-3 virtual interviews (1-2 with Clinical Supervisor + 1 final with CEO)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 Research AR Specialist

Our client is looking for a Remote AR Specialist to help with an unpaid invoicing backlog. This person can sit anywhere and work any hours as long as they are productive. This is a 40 hour a week... More project for 2-3 months. Our ideal candidate is someone who has clinical research experience or B2B collections. Other responsibilities include: ?Contact sponsors regarding aging invoices, payment remittance details and payment status.?Prepare invoices for patient visits and procedures for assigned locations. ?Reconcile all payments and maintain accurate aging of Accounts Receivable.?Recognize issues that may arise when processing or performing all tasks assigned and report such issues to the manager. ?Perform an audit to ensure that all payments, or charges, are in balance or takes the appropriate action. Appropriate action includes communication with manager or controller. ?Respond to basic Accounts Receivable process/billing questions posed by various internal/external parties in a timely and knowledgeable manner.?Other duties may be assigned at any time.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 Research AR Specialist

Our client is looking for a Remote AR Specialist to help with an unpaid invoicing backlog. This person can sit anywhere and work any hours as long as they are productive. This is a 40 hour a week... More project for 2-3 months. Our ideal candidate is someone who has clinical research experience or B2B collections. Other responsibilities include: ?Contact sponsors regarding aging invoices, payment remittance details and payment status.?Prepare invoices for patient visits and procedures for assigned locations. ?Reconcile all payments and maintain accurate aging of Accounts Receivable.?Recognize issues that may arise when processing or performing all tasks assigned and report such issues to the manager. ?Perform an audit to ensure that all payments, or charges, are in balance or takes the appropriate action. Appropriate action includes communication with manager or controller. ?Respond to basic Accounts Receivable process/billing questions posed by various internal/external parties in a timely and knowledgeable manner.?Other duties may be assigned at any time.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