Senior Manager, GCP & Clinical Quality
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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
- Sarepta Therapeutics seeks a Sr. Manager, Corporate Quality - GCP to provide program-level QA oversight across clinical development and real‑world evidence, ensuring compliance with FDA, ICH, and international standards. As a core member of the Clinical Trial Team, you...QualitySenior
$137k - $215.27k
...Planning Group within PharmSci Clinical Manufacturing Planning, which... ...’s clinical portfolio.The Senior Manager contributes to the team’s delivery... ...: CMC / PharmSci, GCSC, Quality, Finance, Program TeamsExternal... ...to incorporate GMP/GDP/GCP considerations into planning...QualitySeniorMinimum wageContract workLocal area- ...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$217.1k - $325.7k
...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$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- 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
...positive company culture. Job Title: Clinical Trial Manager/Senior Clinical Trial Manager Location:... ...planning and executing the study to ensure quality of deliverables within the specified... ..., including FDA, EMA, and ICH-GCP guidelines. Support the preparation...QualitySeniorWork at officeRemote work3 days per week$130.8k - $209.4k
...dedicated to revolutionizing medicine. As a Senior Manager Clinical Data Management, you will play a pivotal role in ensuring the integrity and quality of clinical data that drives... ...knowledge of international guidelines (ICH-GCP) for clinical research projects Experience...QualitySeniorHourly payFull timeFor subcontractor$80k - $150k
Senior Clinical Data Manager, Clinical Data Management, R&D, Orion Corporation and 1 more and 1 more Job... ...integration, review, and delivery of high-quality clinical data that support study... ...CDISC standards (CDASH and SDTM), ICH-GCP requirements, SOPs, and applicable regulatory...QualitySenior$185k
Clinical Development and Validation, Manager Company Description Butterfly Network, Inc. (NYSE: BFLY) is driving a digital revolution in ultrasound imaging... ...carrying out the requirements of Butterfly Network’s quality procedures. Provide clinical support and input cross‑...QualitySeniorH1bWork at officeImmediate start2 days per week$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- ...headquartered in Bedford, MA, seeks an Associate Director of Clinical Quality Compliance to oversee GCP/GCLP compliance across clinical studies. This role... ...readiness. The role emphasizes developing quality management systems, risk-based plans, audits, and investigating deviations...Quality
$136k - $170k
...comprehensive benefits, see our website: The Importance of the Role The Sr. Manager, Corporate Quality - GCP, will provide program-level quality oversight and strategic support across Sarepta’s Clinical Development and Real-World Evidence portfolio. This role serves as a...QualitySenior$235k - $330k
Who we are:Kymera is a clinical-stage biotechnology company pioneering... ...you’ll make an impact:The Senior Director, Clinical... ...for overseeing and managing all aspects of clinical operations... ...timelines, budget, and quality standards (including ICH GCP and local regulations)Develop...QualitySeniorLocal area$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$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- 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
$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- Repertoire Immune Medicines seeks a Senior Clinical Data Manager to lead data management for clinical trials in Cambridge, MA. The role... ...overseeing various vendor activities, ensuring data quality, compliance with GCP and ICH guidelines, and contributing to the successful...QualitySenior
$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$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$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- ...Title: Global Development Senior Medical Director,... ...to help address unmet clinical needs in a host of hematological... ...assets and life-cycle management programsThe Senior... ...compliance FDA, EMEA, ICH and GCP guidelines as well as... ...to improve the quality and content of all clinical...QualitySeniorHourly payFull timeTemporary workWork at officeLocal areaWorldwide
$138k - $190k
...candidates from Deciphera’s platform in clinical studies, QINLOCK (ripretinib) is... .../or dependent care. Job DescriptionThe Senior Manager, Clinical Procurement is responsible for... ...contracts, and ensure timely delivery of high-quality services from external suppliers. The...QualitySeniorContract workFlexible hours$253.33k - $286.67k
...Senior Director, Clinical OperationsCambridge, MACity Therapeutics is seeking a seasoned... ...assigned programs, including trial management, site monitoring, vendor... ...final study reports.Compliance & Quality: Ensure adherence to SOPs and GCP/ICH guidelines; maintain inspection...QualitySenior$124k - $177k
The Opportunity The Sr. Manager, Clinical Business Operations will be responsible for managing vendor... .../contracts to drive accountability, quality and performance. This role is a key... ...clinical study teams and will partner with senior level stakeholders to ensure vendors...QualitySeniorContract work$131k - $187k
...Repertoire Immune Medicines is a clinical-stage biotechnology company... ...continues to expand, the Senior Clinical Data Manager will play a pivotal role in... ...and helping deliver high-quality data that informs critical... ...data in accordance with GCP, ICH guidelines, applicable...QualitySeniorTemporary workWork experience placementWork at officeLocal areaFlexible hours2 days per week3 days per week
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