Clinical Trials Regulatory Steward
Adams Clinical
Adams Clinical seeks a Regulatory Maintenance Specialist for the Watertown site. This on-site role maintains regulatory compliance and inspection readiness from activation through closeout, partnering with site operations to protect data quality and participant safety. The role manages IRB approvals and staff credentialing, resolves sponsor/CRA items, and ensures audit readiness with central start-up support and regular team meetings. #J-18808-Ljbffr Adams Clinical
- ...Director of Biostatistics plays a pivotal role in driving clinical development strategies for innovative drug candidates.... ...cross-functional teams to design and implement clinical trials aligned with regulatory standards and scientific rigor.Contribute to statistical...RegulatoryInterim role
- Dana-Farber Cancer Institute in Boston seeks a Clinical Trials Monitor to ensure regulatory compliance across the DF/HCC consortium. The role includes designing and implementing a robust monitoring program, performing remote reviews and onsite visits, and guiding staff...RegulatoryRemote work
- ...PharmaceuticalsSelling Points Lead impactful clinical operations for neuroscience programs,... ...teams to ensure successful global trial execution. Develop and mentor high-performing... ...clinical development objectives and regulatory requirements.Lead and develop a high-performing...Regulatory
$185.6k - $232k
...provide strategic quality oversight across clinical development and real-world evidence programs... ...ensures GCP and GLP compliance across clinical trials and non-clinical studies, serving as a subject matter expert in regulatory standards and patient safety....Regulatory$213k - $304k
...at Relay Tx, you will help advance our clinical pipeline from IND to proof of concept to... ...staff to drive clinical strategy, clinical trial design, and execution. Working cross-... ...functionally with clinical project management, regulatory affairs, clinical operations,...RegulatoryImmediate startRemote work- Dana-Farber Cancer Institute seeks a Clinical Research Coordinator to support trial conduct under GCP. You will collect and manage patient data, facilitate... ...meticulous data entry, binder maintenance, and regulatory support to uphold trial integrity and patient safety....Regulatory
$71k - $96k
...Senior Clinical Studies Associate The Senior Clinical Studies Associate supports the... ...contributes to study operations, documentation, regulatory compliance, and process improvement... ..., quality review, and completeness of Trial Master File (TMF) documentation. Assist...RegulatoryWork experience placementWork at officeLocal areaRemote work$69k - $99k
...Relay Therapeutics seeks a Senior Clinical Project Associate to coordinate clinical trial operations, manage site activities, and ensure regulatory compliance. The role involves supporting study execution from initiation through closure while collaborating with CROs and...Regulatory- Dana-Farber Cancer Institute in the Boston area is seeking a Clinical Research Manager to lead a disease group’s clinical trial portfolio, ensuring regulatory compliance and performance metrics. You will collaborate with physicians, nursing staff, and research administration...Regulatory
- ...Executive Medical Director overseeing oncology clinical development programs for solid tumors. Leads cross-functional teams in designing, executing, and interpreting clinical trials while ensuring regulatory compliance and advancing product development strategy. Responsibilities...Regulatory
- Nanopath is seeking a Clinical Operations Manager to lead planning, execution, and oversight... ...of clinical studies, including pivotal trials for FDA clearance. This in-person, full-... ...-up, site initiation, monitoring, and regulatory coordination. You will own IRB submissions...RegulatoryFull time
$129k - $184k
...Senior Manager of Clinical Data Management at Relay Therapeutics will oversee data management... ...vendors, and ensure data integrity and regulatory compliance. The role involves database... ...check programs Generate clinical trial data queries, manage review listings, and...RegulatoryFull time- Role: Associate Director, Clinical QA, providing hands-on quality oversight of biopharma'... ...findings and quality metrics assist in regulatory submissions and agency inspections Requirements... ...1, 50, 54, 56, 58, 312, and EU Clinical Trials Regulation ability to travel up to 20%...Regulatory
$170k - $215k
...services company powering the acceleration of clinical research to transform patient outcomes.... ...cardiology. By combining deep clinical trial expertise with cutting-edge AI, we... ...site solutions—including pre-screening, regulatory support, and eSource—you will partner cross...RegulatoryTemporary workWork at office2 days per week$71k - $96k
Hmixray is seeking a Senior Clinical Studies Associate to support planning and execution of clinical studies. This role involves project management, documentation and regulatory compliance, ensuring quality standards throughout the study lifecycle. The ideal candidate has...RegulatoryRemote job- ...this goal every day.Reporting to the VP, Clinical Operations, the Director, Clinical... ...within budget, and in compliance with GCP, regulatory requirements, and company SOPsProvide operational... ...recruitment, site engagement, and trial execution strategies to support...RegulatoryTemporary workWork at officeLocal areaImmediate start3 days per week
- ...Biostatistics to lead statistical activities across early to late-stage clinical trials. You will design, analyze, and interpret statistics, develop SAPs, and collaborate with pharmacometrics, regulatory, and CRO partners. The ideal candidate holds a doctorate in...Regulatory
- ...Dyne Therapeutics seeks an Associate Director to lead clinical trial operations, translating clinical strategies into executable plans and... ...across all phases. The role involves managing CROs, ensuring regulatory compliance, and coordinating cross-functional initiatives in...RegulatoryContract work
- ...Senior Scientific Director position overseeing clinical development programs in non-Hodgkin's lymphoma and leukemia. Leads... ...designing, implementing, and interpreting complex oncology trials while ensuring regulatory compliance and scientific rigor. Responsibilities...Regulatory
- ...services company powering the acceleration of clinical research to transform patient outcomes.... ...cardiology. By combining deep clinical trial expertise with cutting-edge AI, we... ...employees world-wide.As a Senior Clinical Regulatory Specialist at Iterative Health, you will...RegulatoryTemporary workWork at office2 days per week
$165k - $200k
Department: 1440GL - Clinical OperationsLocation: Waltham, MACompany Overview:Dyne Therapeutics... ...for initiating and leading clinical trials across all phases, including overseeing... ...including ICH GCP guidelines, local regulatory requirements, and Dyne’s policies ad SOPs...RegulatoryLocal area$164k - $199k
...scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and... ...of ICH/GCP guidelines and working knowledge of regulatory guidelines/directives.Proficiency in trial...RegulatoryContract workLocal area$207k - $253k
...Director, Clinical Operations Massachusetts - Hybrid Join our team in a dynamic hybrid... ...partners to drive high-quality clinical trial delivery in a fast-paced, small-to-... ...management. Assist in authoring key regulatory documents and ensure that clinical program...RegulatoryWork at officeRemote workFlexible hoursShift work$109.9k - $179.3k
...Associate Manager overseeing clinical imaging operations for early and late phase trials across diverse modalities including ultrasound, MRI, CT, and DXA. Role... ...teams, and sites to ensure data integrity, regulatory compliance, and successful trial execution from startup...Regulatory$171k - $273k
Job TitleDirector of Clinical OperationsJob DescriptionDirector of Clinical Operations, Image... ...while leading complex negotiations with regulatory bodies, sites, and vendors and... ...operational planning and execution of clinical trials and evidence generation programs across...RegulatoryFull timeContract workWork at officeLocal areaImmediate startWork visaRelocation package3 days per week$210k - $245k
...Overview Repertoire Immune Medicines is a clinical-stage biotechnology company harnessing... ..., has initiated a Phase 1/2 clinical trial across multiple solid tumor indications.... ...therapies designed to selectively expand regulatory T cells and reset the immune system....RegulatoryTemporary workWork experience placementWork at officeFlexible hours3 days per week- ...Regeneron seeks a Senior Director to lead clinical trial liaison strategy within Global Clinical Operations. This senior leadership role... ...scientific development Working knowledge of ICH/GCP and current regulatory guidance (ICH E6(R3), RBQM) Advanced negotiation and...Regulatory
$330k - $355k
...Senior Director, Clinical Development Triveni Bio is breaking new ground in the identification... ..., safety reviews, data interpretation, regulatory submissions, publications, and... ...into development strategies. Clinical Trial Design & Execution Drive the development...RegulatoryFull timeFor contractors$247.1k - $334.3k
...levels and functional areas and partners closely with the clinical development, regulatory, and commercial teams. The exceptional candidate that we... ...teams regarding all aspects of clinical safety, including trial design, appropriateness of safety endpoints, analysis and...RegulatoryFull timeTemporary workLocal areaFlexible hours$275k - $285k
...Senior Director, Clinical Operations Cambridge, Massachusetts or Oakland California... ...teams to deliver high-quality clinical trials on time and within budget. The Senior Director... ...ICH-GCP, FDA, EMA, and other applicable regulatory requirements governing clinical research...RegulatoryFull timeContract workLocal area
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