Senior Manager, GCP & Clinical Quality
Socket.dev
Sarepta Therapeutics is seeking a Sr. Manager, Corporate Quality – GCP to provide program-level QA oversight across Clinical Development and Real-World Evidence. You will ensure GCP compliance and guide trial teams through audits, CAPAs, and vendor assessments. Join a team focused on delivering high-quality clinical programs with global scope, including vendor management, inspections, and continuous quality improvements. #J-18808-Ljbffr Socket.dev
- ...Senior Manager, Clinical Data Management Burlington, MA Working with Us MBX Biosciences is... ...activities across MBX portfolio to ensure high quality and inspection ready clinical... ...Biostatistics. ~ Solid knowledge of ICH-GCP, regulatory requirements, and...QualitySeniorInterim roleWork at office
$229.8k - $381.7k
...leadership across rheumatology/immunology clinical development programs with scientific... ...Ops, Safety, Biostatistics, Regulatory, Quality, Medical Affairs, and Market Access to ensure... ...and lead global trials in a matrixStrong GCP/ICH knowledge; familiarity with FDA/EMA requirementsExcellent...QualitySeniorFlexible hours3 days per week$130k - $190k
...a motivated and experienced Clinical Data Management professional to serve as the... ...portfolio.Reporting to the Senior Director of Data Management,... ...database lock while ensuring high-quality, inspection-ready clinical... ...of CDASH/CDISC standards, GCP/ICH requirements, and...QualitySeniorFull timeInterim role$134.5k - $168.23k
Zenas is a clinical-stage global biopharmaceutical company committed... ...!Position Summary:The Senior Manager, Clinical Laboratory Operations... ...Operations, Data Management, Quality Assurance, Procurement, Legal... ...functionallyFamiliarity with GCP, ICH guidelines, informed consent...QualitySenior$251k - $409.3k
...in the US. Your RoleAs a Senior Medical Director in Global Clinical Development Oncology, you... ...forums, and help ensure high-quality and timely delivery of... ...with ICH-GCP, FDA and/or EMA expectations... ...developmentExperience mentoring, guiding, or managing medical team...QualitySeniorWork at officeFlexible hours$253k - $300k
...Senior Director, Clinical Operations Lexington, MA (Hybrid) At Keros, our... ...(or similar) ensuring high quality, feasible trials are planned... ...escalation for resolution of trial management operational issues. The... ...FDA, EMEA, GDPR, ICH and GCP regulations and guidelines...QualitySeniorHourly payFull timeContract workLocal area$147.9k - $200.1k
...Senior Manager, Clinical Data Management The Senior Manager, Clinical Data Management will lead... ...industry best practices; Support GCP inspection readiness and participate as... ...Clinical Operations, Clinical Research, Quality Assurance, Global Patient Safety and...QualitySeniorFull timeTemporary workFlexible hours$156k - $175k
...communities we serve. We are a clinical-stage company currently... ...Opportunity The Clinical Data Management team at Amylyx... ...and mitigating risks to data quality and proper inclusion into the... ...working knowledge of FDA & ICH/GCP regulations and guidelines...QualitySeniorLocal areaRemote work- Sr. Manager/AD, Clinical Data Management & Systems Join Apex Systems as a strategic data leader to... ...functional collaboration to deliver high‑quality insights that shape clinical... ...‑making Oversee EDC systems and ensure GCP/GCDMP compliance Collaborate with Biostats...QualitySenior
$146k - $161k
...Clinical Trial Manager/Senior Clinical Trial ManagerWaltham, Massachusetts, United StatesOruka Therapeutics... ...and executing the study to ensure quality of deliverables within the specified budget... ..., including FDA, EMA, and ICH-GCP guidelines.Support the preparation and...QualitySeniorWork at officeRemote work3 days per week$138k - $190k
Job Description The Senior Manager, Clinical Quality Assurance is responsible for the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by Deciphera. The primary responsibilities are to ensure both quality and compliance...QualitySeniorContract work$75 - $84.64 per hour
...delivery support for assigned Clinical Trial Delivery and Pharmacovigilance... ...in accordance with applicable quality and document-control... ...environment. Ability to organize and manage multiple assigned deliverables... ...expectations, including ICH GCP. Experience facilitating...QualitySeniorHourly payContract workTemporary workWork experience placementRemote work$130k - $170k
...Description SEISMIC THERAPEUTIC Clinical Trial Manager / Senior Clinical Trial Manager About Seismic... ...against scope, timelines, budget, quality standards, and study objectives, and... ...appropriately. ~ Working knowledge of ICH-GCP, applicable FDA and global regulatory...QualitySeniorWork at officeLocal areaRemote workShift work$185k
take part in validating design outputs. Clinical Development and Validation, Manager Company Description Butterfly Network, Inc. (NYSE: BFLY) is driving... ...carrying out the requirements of Butterfly Network’s quality procedures. Provide clinical support and input cross-...QualitySeniorH1bWork at officeImmediate start2 days per week$115k - $215k
Who we are:Kymera is a clinical-stage biotechnology company pioneering... ...make an impact:Negotiate and manage contracts, including Master... ...budget analyses to support senior leadership vendor-award decisions... ..., ensuring high standards of quality and compliance.Understand and...QualitySeniorContract work$284.63k
...DPosition SummaryAs SERM Senior Medical Director, Oncology, you will lead clinical safety and... ...identification, escalation and management of safety issues.Working... ...OncologyProven record of high-quality, timely decision-making... ...Clinical Practice (GCP), Influencing Without...QualitySeniorFull timeWork at officeLocal areaRemote work2 days per week- ...Us in Shaping the Future of Clinical Research Adams Clinical... ...deliver uncompromising data quality, safety, and diverse enrollment... ...our team. Job Role The Senior Manager provides site-level... ...required ~ Knowledge of GCP, FDA regulations, and clinical...QualitySeniorWork at officeLocal areaRelocation
$252k - $269k
This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality programs to ensure compliance across global clinical trials... ...for inspections, implements and manages risk-based quality systems, collaborates...QualitySeniorContract workWork at officeLocal areaWorldwideFlexible hours3 days per week- This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality programs to ensure compliance across global clinical trials... ...for inspections, implements and manages risk-based quality systems, collaborates...QualitySeniorContract work
- ...Senior Clinical Data Manager The Senior Clinical Data Manager is responsible for study Data Management activities from study start up to close... ...Management timelines for assigned studies. Manage performance, quality, and timeliness of data from service providers (e.g.,...QualitySenior
$236.25k - $393.75k
Job title: Senior Clinical Research DirectorLocation: Cambridge, MAClinical... ...operations, project management, and procurement), responsible... ...with Good Clinical Practice (GCP), applicable laws and regulations... ...benefits including high-quality healthcare, prevention and wellness...QualitySeniorFull time$284.25k
...meaningful impact in the real world.The Senior Medical Director, Oncology Clinical Development - Lung is a senior... ...programme, supporting consistency and quality of medical input across... ...of clinical development processes, GCP, ICH guidelines, and global regulatory...QualitySeniorFull timeWork at officeLocal areaRelocation2 days per week$284.25k
...proposed to take effect by early 2029.The Senior Medical Director, Oncology Clinical Development - Sarcoma, is a senior... ..., supporting consistency and quality of medical input across studiesSupport... ...of clinical development processes, GCP, ICH guidelines, and global...QualitySeniorFull timeWork at officeLocal areaRelocation2 days per week$145.9k - $234.2k
The Role:Moderna is seeking a Senior Product Manager - Clinical Safety and Pharmacovigilance Systems to support the digital product strategy, operations... ...closely with stakeholders in Patient Safety, Regulatory, Quality, Clinical Development, and Digital, as well as global...QualitySeniorPermanent employmentFull timeWork at officeWork from home$284.63k
...DPosition SummaryYou will lead clinical development medical... ...a Clinical Development Senior Medical Director to... ...project strategies to ensure quality design and execution of... ...Inspiring Others and Managing Conflict • Consistently... ...Clinical Practice (GCP), and ethical guidelines...QualitySeniorFull timeLocal areaRemote workRelocation2 days per week$284.25k
The Senior Medical Director, Oncology Clinical Development - GU will report to the Executive... ...also have a leading role in managing effective relationships... ...the development of high-quality protocols aligned with the... ...knowledge and adherence to GCP principles.SkillsClinical...QualitySeniorFull timeWork at officeLocal areaWorldwide2 days per week$210.9k - $379.2k
...oncology drug developer lead Clinical Development for one or more mRNA... ...command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate... ...drive to generate high-quality work, and sense of passion and... ...goalsDemonstrated experience managing complex projects and working collaboratively...QualitySeniorPermanent employmentFull timeWork at officeWork from home- Beth Israel Lahey Health is seeking a Primary Care Practice Manager to oversee daily operations of a high-volume, multi-provider primary care practice. You will collaborate with clinical leaders to foster quality care, staff development, and process improvements that...QualitySenior
$275k - $285k
...Senior Director, Clinical OperationsCambridge, Massachusetts or Oakland CaliforniaAt... ...teams to deliver high-quality clinical trials on time and... ...ImprovementEnsure compliance with ICH-GCP and applicable global... ...governance, performance management, quality oversight, and...QualitySeniorFull timeContract workLocal area$296k - $355k
...experienced, highly motivated Senior Medical Director, Clinical Development to join our... ...recruitment strategies, and high-quality trial execution Oversee... ...~ Understanding of GCP, clinical trial design, regulatory... .../tools ~ Ability to manage multiple studies and deadlines...QualitySeniorFull timeLocal areaFlexible hours3 days per week
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