GCP Quality Lead for Phase I-III Trials
Monte Rosa Therapeutics
A biopharmaceutical company based in Boston is seeking a GCP Quality expert to oversee quality activities for Phase I-III clinical trials. This role includes acting as the primary GCP Quality contact for vendors, managing GCP quality events, and authoring GCP SOPs. The ideal candidate will have at least 8 years of industry experience and a BS Degree in a relevant field. Join us in developing innovative therapies for cancer and other diseases through cutting-edge science and a mission-driven approach. #J-18808-Ljbffr Monte Rosa Therapeutics
$196k - $240k
...Therapeutics is seeking a Director, Clinical Scientist to lead the scientific execution of clinical trials. This senior position requires extensive experience... ...data, authoring trial documents, and ensuring high-quality trial conduct. A strong background in clinical trials...Quality$250k - $290k
Senior GCP Quality Assurance Lead - Permanent - Boston - Remote Take the lead in delivering world‑class... ...Additional Responsibilities Ensure clinical trials are conducted, documented, and... ...procedures. Serve as the QA lead across late‑phase clinical programs, from protocol...QualityPermanent employmentRemote work- ...lives of patients and their families. Our lead product candidate, pridopidine, holds... ...of HD. Prilenia is conducting global Phase 3 clinical trials in both HD and ALS. Pridopidine has... ...About the role The Director/Sr. Dir, GCP Quality Assurance is Prilenia's primary quality...QualityFull timeRemote workFlexible hours
$122.25k - $176.58k
...MA or Morristown, NJ. This role involves leading multiple phase 2 or 3 studies, developing statistical solutions to influence trial decisions and drug development. The ideal... ...clinical trials. Offered benefits include high-quality health care and a salary range of $122,250...Quality- Vertex Pharmaceuticals Inc (US) is seeking a Clinical Study Quality Lead to oversee quality assurance for clinical trial operations, ensuring compliance with GCP standards. The ideal candidate will contribute to audit and quality plans, manage compliance risks, and drive...Quality
- ...Center in Boston, MA is seeking a Clinical Research Coordinator III for a hybrid role. The CRC will conduct various clinical research... ...and data management, as well as assist with audits and quality improvement projects. Ideal candidates must have a Bachelor’s degree...Quality
- A leading biopharmaceutical company is seeking a GCP Quality Specialist in Boston to oversee GCP quality for clinical programs. You will manage vendor interactions and support the documentation of GCP quality events. The ideal candidate will hold a BS Degree in a life...Quality
$69.91k - $90.88k
American Health Quality Association is seeking a Health Science Specialist (Quality Assurance) for the VA Boston Healthcare System. This... ...and maintaining quality assurance programs within clinical trials, ensuring compliance with regulatory standards. The ideal candidate...Quality- Looking for a GCP Quality expert to work on implementing quality from work for our on going Phase I-III clinical trials. Responsible for support of phase-appropriate Monte Rosa Quality... ...Combining deep knowledge, insight and leading‑edge science, our integrated engine is...Quality
- Monte Rosa Therapeutics, Inc is looking for a GCP Quality professional in Boston, Massachusetts. The role involves ensuring quality oversight of clinical programs, managing GCP quality events, and conducting audits of vendors and investigator sites. The ideal candidate...Quality
$250k - $290k
Proclinical Group is seeking a Senior GCP Quality Assurance Lead to oversee quality assurance for clinical development initiatives in Boston. This role requires extensive experience in GCP QA within biotech or pharmaceutical environments. The successful candidate will...Quality- Beth Israel Lahey Health is seeking a Clinical Trials Monitor (CTM) based in Boston, Massachusetts. The CTM will oversee and audit clinical... ...adherence to Good Clinical Practice, and improving research quality. Candidates should possess a Bachelor's degree in Life Sciences...QualityRemote jobCasual work
$78 - $86 per hour
.... Clinical Study Associate III This position requires 3x... ...Support day‑to‑day clinical trial activities in partnership with... ...select sites. Ensure data quality and assist in resolving... ...of Good Clinical Practices (GCP), SOPs, and study phases in clinical development. Technical...QualityContract work$145k - $160k
...are seeking a Clinical Trial Manager (CTM) to join our... ...trial programs (Phases I-III). Your responsibilities... ..., and maintaining data quality suitable for regulatory... ...with internal functional leads, CROs, and vendors to ensure... ..., ICH guidelines/GCP and specifically each step...Quality$130k
...integrations across the SDLC, it sets a new quality standard for application delivery teams.... ...Join us in our mission. Account Executive III, Functional Test Drive strategic revenue growth... ..., and identities because we know it leads to better outcomes. Did you know? Our main...QualityWorldwideFlexible hours- ...efficient scale-up, a consistent, quality supply, or any combination... ...conceptualization and validation phase through release to... ...etc.) preferred Class I, II, III medical device manufacturing experience... ...skills Demonstrated ability to lead projects and get results through...QualityWork at officeFlexible hours
- ...Compliance Supervisor - Program Coordinator III (260002G9) MassHire Department of Career... ...Compliance Supervisor conducts comprehensive quality assurance and compliance monitoring across... ...of programs. Coordinate, schedule, lead, attend, and participate in meetings, workshops...QualityFull timeContract workPart timeWork at officeLocal area
- ...Principal Biostatistician based in Boston, MA, to lead statistical activities for clinical trials across various phases. You will provide statistical support and... ...with cross-functional teams while ensuring high-quality outputs. The ideal candidate should have a Bachelor...Quality
- ...in Boston is seeking a Director of Biostatistics to lead statistical strategy for Phase 1-3 clinical trials, primarily in oncology and inflammatory diseases.... ...methodologies, overseeing outsourced teams, and ensuring the quality of statistical deliverables. This role combines...Quality
- A leading biopharmaceutical company seeks a skilled Medical Director for Oncology.... ...oncology development and expertise in Phase I and II clinical trials. The candidate will lead clinical... ...ensuring adherence to regulations and quality across studies. Strong leadership, analytical...Quality
- Xenon Pharmaceuticals Inc. is seeking a Director, Quality Assurance, GCP/GLP to join their Needham, MA office. This role involves leading quality oversight for clinical programs and ensuring compliance with regulatory standards as the company advances its drug development...QualityWork at officeRemote work
$70 - $125 per hour
Job Title: Quality Systems Analyst Location: Boston, MA Contractor Work Model: Onsite Hours... ...GMP production and testing of clinical trial materials at contract development and... ...well as assisting with the maintenance of phase‑appropriate quality systems, including GxP...QualityPermanent employmentContract workFor contractorsLocal area$100.28k - $110k
...Job Title SAP Functional Analyst III, BUWorks, Human Capital Management Job Overview... ...with clients and developers to deliver high‑quality outcomes. Position Details Location:... ...support tickets. Define and execute test phases within project implementations. Required...QualityFull timeFor contractors- ...working on projects spanning across all phases of global clinical trials, in a wide array of therapeutic... ...level for candidates with experience leading global studies in a variety of therapeutics... ...within budget and to the highest quality with the goal to exceed client...QualityRemote work
- ...Research Coordinators at multiple levels, to support late-phase, industry-sponsored clinical trials across psychiatric and neurological indications. This... ...growth and expanded responsibilities Exposure to high-quality, late-phase clinical trials #J-18808-Ljbffr BioTalent...Quality
- ...Job Title: Clinical Trial Associate Contract Term... ...Coordination Required Leading the trial is preferred... ..., maintenance phase, and study close out procedures... ...Good Clinical Practice (GCP) and the Code of... ...Strong attention to quality/detail Good organizational...QualityContract workFlexible hours
$315k - $340k
...Vice President, Quality Assurance Olema Oncology is... ...cancer and beyond. Our lead program, palazestrant (OP... ...executive level and ensures a phase-appropriate, risk-based... ...leadership team across GCP, GMP, and GPV - aligning... ...of oncology clinical trials Provide oversight of...QualityWork at officeFlexible hours$122k - $150k
...Intermediates, Drug Substance, and Drug Product Prepare batch file for final batch disposition for Kailera’s Phase I‑III clinical programs Review GMP Quality Events, change controls, CAPA’s, and other GMP documentation as needed Identify and escape issues effectively...QualityLocal areaFlexible hours3 days per week- ...for a Senior Clinical Trial Manager to join their Clinical... ...supporting an exciting Phase 2 open-label dose... ...clinical study report, leading cross-functional study... ...ensure on-time, on-budget, quality delivery. This is a... ...CRO oversight ensuring GCP and protocol compliance...QualityPermanent employmentContract workLocal areaRelocation2 days per week3 days per week
- ...opening for a Transportation Engineer III, Traffic to join our team. The... .... Review work produced by staff for quality assurance. May serve as a lead/resource among team of colleagues in... ...assignments and lead the efforts on all phases of a variety of transportation projects...Quality
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