POSITION SUMMARY: The Oncology Pathology Assistant provides assistance to the Signatera team as a subject matter expert for review of clinical pathology reports and clinical notes. The Oncology Pathology Assistant will assist the medical and customer service teams with acquisition of appropriate specimens for minimal residual disease (MRD) testing in oncology. PRIMARY RESPONSIBILITIES: Assist the medical and customer service teams with the interpretation of oncology pathology reports to identify optimal samples to request when initial FFPE blocks or slides are inadequate for testing. Read and ensure accurate curation of clinical history, diagnosis, progress notes, and specimen information is entered into the Signatera sample database. Assist with devising strategies to stratify data for retrieval from the Signatera sample database and other databases as necessary. Maintain proficiency with and help organize diagnostic data according to pertinent WHO guidelines. Serve as subject matter expert to the Laboratory Director, Genetic Counseling, Customer Experience, Sales, and Clinical Trial teams for pathology reports. Assist in the identification and alert the Laboratory Director when samples may have been collected at suboptimal timepoints and/or fixative conditions. Assist Genetic Counseling and Customer Experience teams in identification and procurement of optimal additional samples, as necessary. Provide professional support for the Clinical Trial team through accurate and organized data transfer. Performs other duties as assigned. QUALIFICATIONS: Bachelor’s degree, or higher, with certification by the American Society of Clinical Pathology (ASCP), or equivalent board, is required. Minimum of 10 years of experience in anatomic pathology including extensive knowledge of solid tumor pathology. KNOWLEDGE, SKILLS, AND ABILITIES: Ability to accurately understand and convey information found in anatomic pathology reports to team members for a wide
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ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Key Responsibilities Lead and provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables Author and review key statistical documents, including: Statistical Analysis Plans (SAPs) Analysis Database Specifications (ADS) Statistical sections of clinical study reports Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory Provide guidance and oversight to statistical programmers as needed Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs Required Qualifications MS or PhD in Statistics, Biostatistics, or a related field Strong experience in Oncology studies Hands-on experience writing: Statistical Analysis Plans (SAPs) Analysis Database Specifications Reviewing and interpreting analysis results SAS programming skills required (hands-on or strong working knowledge) Excellent written and verbal commun
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Key Responsibilities Lead and provide statistical support for clinical studies. Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables Author and review key statistical documents, including: Statistical Analysis Plans (SAPs) Analysis Database Specifications (ADS) Statistical sections of clinical study reports Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory Provide guidance and oversight to statistical programmers as needed Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs Required Qualifications MS or PhD in Statistics, Biostatistics, or a related field There are no specific therapeutic area requirements; however, experience in Oncology, Rare Disease, or Neuroscience would be advantageous. Strong oral and written communication skills, with the ability to effectively communicate internally and with clients. Demonstrated understanding and insight in statistics, drug
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Key Responsibilities Lead and provide statistical support for clinical studies, primarily within Oncology Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables Author and review key statistical documents, including: Statistical Analysis Plans (SAPs) Analysis Database Specifications (ADS) Statistical sections of clinical study reports Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory Provide guidance and oversight to statistical programmers as needed Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs Required Qualifications MS or PhD in Statistics, Biostatistics, or a related field Strong experience in Oncology studies Hands-on experience writing: Statistical Analysis Plans (SAPs) Analysis Database Specifications Reviewing and interpreting analysis results SAS programming skills required (hands-on or strong working knowledge) Excellent writt
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary This position is for a Clinical Pharmacist working in the Prior Authorization team. - Collaborates with the technicians and prior authorization team members to process referrals, including answering clinical questions and collecting appropriate clinical/medical data needed to perform clinical assessments and reviews as per the health plan/employer-agreed criteria within the designated service level agreements. - Evaluate and review all prior authorization requests and render coverage determinations based on clinical criteria and plan design. Includes verifying insurance coverage and eligibility, interpreting clinical guideline criteria, consulting physicians and other healthcare providers, and appropriately utilizing clinical knowledge and resources while complying with department protocols. - One of the crucial responsibilities is to guarantee that the decisions regarding cases are conveyed promptly and efficiently to all the healthcare providers, health plans/employers, patients, and other healthcare professionals following agreed-upon approval & denial management processes. - Performs and handles inbound and outbound phone calls with technicians, prior authorization team members, physicians, healthcare providers, and/or patients to facilitate prior authorization requests, answer inquiries, and/or resolve escalations. - Establishes and maintains communicat
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate , throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions. You will make an impact: Experienced Clinical Data Manager with expertise in the review and reporting of clinical data throughout the entire data lifecycle. Proven track record of developing comprehensive study documentation, designing, implementing, and managing data deliverables from start-up to closeout in adherence to industry standards and regulatory requirements . Skilled in fostering collaboration among clinical operations, biostatistics, and programming teams to integrate data management activities and enhance operational efficiency. Committed to continuous improvement by staying knowledgeable of emerging technologies and industry trends to implement best practices for effective and efficient data management. Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. Your day to day: Acts as support for primary DM representative for eClinical Solutions and sponsor data management interaction, ensure eClinical Solutions data management pro
Clinical Database Programmers are operationally responsible to provide technical support and oversight for the Medidata Clinical Cloud (MCC) implementation activities. Clinical Database Programmers will maintain project level perspective, focus and communicate effectively as the MCC SME on technical and functional electronic data capture programming and data management activities, timelines and deliverables. KEY TASKS & RESPONSIBILITIES Design/develop and test clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, standard and custom reports Performs peer review for the studies built by other Clinical Database Programmers Responsible for the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules Manages timely-quality deliverables for the study teams for assigned protocol/study(s) Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to Data Management, operations teams, and other stakeholders on basic Medidata Rave functionality Working knowledge of additional Medidata Rave modules, including Coder, RTSM, Lab Admin, iMedidata/Cloud Admin or other modules. Other duties as assigned CANDIDATE’S PROFILE Education & Experience Bachelor’s degree or equivalent work experience preferred 2+ years in Pharmaceutical/Biotechnology industry or equivalent preferred Experience with requirements gathering, design and specification development of CRFs, edit checks, site queries, and understanding of database structures and programming languages Professional Skills Ability to work creatively and independently to carry out assignments of a complex nature Ability to communicate and work effectively and cooperatively with other professional staff members Detail oriented, ability to multitask with str
Become a part of our caring community The Care Coach evaluates member's needs and requirements to achieve and/or maintain optimal wellness state by guiding members/families toward and facilitate interaction with resources appropriate for the care and wellbeing of members. The Care Coach 1 work assignments are often straightforward and of moderate complexity. Scheduled Hours This is a remote position. The first 4 weeks of training will be from 8:30 AM to 5:00 PM EST. After training, the work hours are Monday-Friday from 10:00 am – 6:30 pm EST. No time off is permitted during the first month of training. The first 90 days following training are critical in building your foundation; therefore, planned or unplanned time away should be minimized as much as possible. Key Responsibilities Conduct telephonic outreach (primarily via auto-dialer) to members with multiple chronic conditions and financial or functional barriers. Assess member needs through data review, structured assessments, and direct conversation to develop and manage individualized care plans. Coordinate services and connect members to appropriate clinical, community, and multidisciplinary resources to support optimal health outcomes. Ensure proper adherence to compliance. Identify and resolve barriers that impede effective care and member independence. Continuously monitor progress toward desired health outcomes and adjust care strategies as appropriate. Maintain strict adherence to compliance requirements within a highly regulated and highly visible program. Learn and navigate multiple computer systems simultaneously while engaging members in a fast-paced, structured environment with limited schedule flexibility. Use your skills to make an impact
Location: On-Site in Boulder, CO (Foresight Dx business unit, a Natera company) Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer. We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us. Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day. About The Role The Clinical Lab Supervisor is a leader in Natera's lab operations whose role is to oversee employees' performance and serve as a liaison between employees and senior management to meet company goals and quality objectives. The supervisor is responsible for daily supervision of lab staff performing duties such as laboratory testing and data review. Duties include but are not limited to coaching, motivating, staffing, evaluating, and training staff. The supervisor works closely with the manager to ensure company and team goals are met while adhering to good manufacturing practices and CLIA/CAP guidelines. What You Will Do Responsible for day-to-day staffing/scheduling/setting up sample run schedules. Ensures production work is consistently completed according to department goals. Ensures all case samples are processed and accounted for. Monitors team members to ensure adherence to SOPs and safety procedures. Oversees training f
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Position Summary The Supervisor, Clinical Health Services is responsible for oversight of healthcare management staff, including the organization and development of high performing teams. In this role, you will: Oversee a non-clinical DE staff Work closely with functional area managers to ensure consistency in clinical interventions supporting our members. Be accountable for meeting the financial, operational and quality objectives of the unit. Oversee the implementation of healthcare management services for assigned functional area. Implement clinical policies & procedures in accordance with applicable regulatory and accreditation standards (e.g. NCQA [ National Committee for Quality Assurance ], URAC [ Utilization Review Accreditation Commission ], state and federal standards, and mandates as applicable). Serve as a content model expert and mentor to the team regarding practice standards, quality of interventions, problem resolution and critical thinking. Ensure implementation and monitoring of best practice approaches and innovations to better address the member's needs across the continuum of care. May act as a liaison with other key business areas. May develop/assist in development and/review new training content. May collaborate/deliver inter and intra-departme
On-site | Vancouver Office – 564 Beatty St About the role Our dentist business is being rebuilt, and we need someone who actually knows digital dentistry to stand beside our customers while we do it. Right now, dentists who send us digital cases are largely unsupported. There's no one dedicated to following up after a case comes in, answering design questions before they become problems, or helping a practice get more out of the platform. That work currently sits with one person who is also covering the lab side and simply doesn't have the hours. You would own it. You are the person a dentist talks to about their case — the one who understands what makes a case good, can say so plainly, and can push back when a clinician has it wrong. This is not a design seat. You are not producing the cases yourself. What you'll do Talk to dentists. Proactive follow-up after cases are submitted, consultation when they have questions, troubleshooting when something goes wrong. Review cases. Assess case quality and design architecture, and advise on how to get better outcomes. Grow existing accounts. Work with practices already sending to us on how to send more, and more of the right kind. Feed the product. Bring what you hear from dentists back to marketing, engineering, and product so the platform keeps improving. Spot the advocates. Identify customers who could become key opinion leaders for the business. What success looks like In your first 6–12 months, ranked: Increase case volume from existing dentist customers by 25% Build genuine working relationships across the customer base Identify and develop customer KOLs for the business What you'll decide on your own You'll own the day-to-day: who to call, what to escalate, what gets discussed with customers, and small refunds and credits. Larger refunds go to your manager. This role does not manage people. What we need from you Hands-on digital case design experience. You have designe
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science. KEY TASKS & RESPONSIBILITIES Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data Monitor and interpret key performance indicators (KPIs), metrics, dash
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Job Description Position Overview The Clinical Laboratory Scientist I performs laboratory analysis on clinical specimens using established laboratory procedures within the assigned department/laboratory. The Clinical Laboratory Scientist I duties will include, but are not limited to, processing of specimens, performance of moderate and highly complex analytical testing, establishing, performing, and documenting quality assurance, quality control, equipment maintenance, and accurately documenting all work performed under the direction of the Laboratory Medical Director. As a Clinical Laboratory Scientist I, you will recognize and resolve problems using good laboratory practices. Shift: Sat - Mon, 6p - 630a Essential Duties (include but are not limited): Perform moderate and highly complex laboratory tests, procedures, and analyses according to the laboratory’s standard operating procedures. Perform, review, and document laboratory quality control procedures. Operate, maintain, and troubleshoot laboratory equipment. Prepare reagents required for laboratory testing. Identify and troubleshoot basic problems that adversely affect test performance and/or laboratory operations. Achieve and maintain competency on laboratory tasks. Assist with mentoring new laboratory personnel on current and new procedures, as needed. </
JOB DESCRIPTION: Plan, coordinate and oversee all start-up activities of internal disciplines (Drug supply, Regulatory, Safety, Data Management etc.) and being the main contact (supervise, steer etc.) for involved CROs and other external vendors, if applicable Agree and/or ensure implementation of study principles and deliverables (safety, timelines, quality, milestones, budget, etc.) and follow-up to guarantee adherence Facilitate communication and ensure adequate collaboration between all involved parties Communicate effectively processes to in-/external service groups and clients in accordance with all applicable procedures (e.g. BIOM, Task List etc.) Participate in teams related to trial conduct (e.g. Clinical Study team, Extended Joint Abbott- CRO Clinical Team, Drug supply team etc.) and organize/attend external key study meetings (Kick-off meeting, CRA meeting, Investigator meeting, etc) as applicable Read, review and/or assist in preparation of core project documents (e.g. Investigator Brochure, Concise Clinical Development Plan, Protocol, Informed Consent Form) as applicable Review key Clinical Trial Management strategies like: Communication plan / Feasibility / Patient & Site recruitment / Drug supply / EC&RA Submission, etc. Oversee and manage with the CRO Project Manager the study conduct in order to ensure adequate and timely delivery of study data and documentation in Trial Master File (TMF): Use efficiently tools to monitor status of e.g. patient recruitment and take corrective action if necessary Ensure respect of agreed deliverables, and communicate efficiently within the teams (timelines, milestones, budget, quality) Co-coordinate timely availability of all supplies important for the conduction of trials, including the re-supply of sites Monitor data c
JOB DESCRIPTION: We currently have an exciting opportunity for a Senior Clinical Data Management Analyst to join our Data Management team. The role comprises of providing clinical data management expertise for the Clinical Affairs and R&D departments across Abbott's Diabetes Care product range. We are keen to hear from candidates looking for an opportunity to make an impact at work and contribute to patient health for the next generation of glucose monitoring technology. The Opportunity In this role, you would be joining a vibrant, friendly and inclusive group of Data Managers, EDC programmers and Statistical Programmers, where you can expect to work across a varied range of clinical trials and R&D projects. Key activities as a Senior Clinical Data Management Analyst include: Lead and direct data management activities in support of Clinical Affairs and R&D. Develop and maintain data management processes, procedures, and best practices. Support clinical studies, including CRF design/review, database build and validation, creation of data management documents. Participate in clinical study teams and liaise with other departmental groups to establish priorities and communicate schedules. Essential Skills and Experience You will have a BSc (or higher) in a scientific or technical discipline. Previous experience working in a regulated clinical data management environment is advantageous. We will expect you to be able to successfully contribute to and manage a small number of projects, and work with colleagues from a range of backgrounds to implement data management processes. Additionally, you’ll need to be adaptable, have a keen eye for detail, excellent written and verbal communication abilities, strong collaboration and team-working skills.</p
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