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
- Sarepta Therapeutics is seeking a Sr. Manager, Corporate Quality - GCP to provide program-level quality oversight across our Clinical Development and Real-World Evidence portfolio. You will act as a subject matter expert in GCP compliance and work with trial teams to ensure...QualitySenior
$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$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$229.8k - $381.7k
...Shift: No Department: HC-RD-OC Clinical Development Immunology... ...Safety, Biostats, Regulatory, Quality, Medical Affairs, Business Franchise... ...leadership and mentoring; may manage direct reports depending on... ...rheumatology ~ Strong understanding of GCP, ICH, FDA/EMA requirements ~...QualitySeniorLocal areaImmediate startShift work$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... ...~ Familiarity with GCP, ICH guidelines, informed consent...QualitySeniorFull time- 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
$173.39k - $210.11k
Senior Manager, Global Clinical Science Position Summary / Objective Will be responsible for design and execution... ...Requirements Basic knowledge of GCP/ICH, drug development process, study... ...Detail‑oriented with commitment to quality. Basic knowledge of disease area,...QualitySeniorFull timeTemporary workFlexible hoursShift work$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$173.39k - $210.11k
## Senior Manager, Global Clinical Science, NeuroscienceCambridge Crossing - MA - USFind out how well you... ...Experience Requirements*** Basic knowledge of GCP/ICH, drug development process, study... ...* Detail-oriented with commitment to quality* Basic knowledge of disease area,...QualitySeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$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$195k - $275k
Who we are:Kymera is a clinical-stage biotechnology company... ...standards.Partner with senior leaders in Clinical Development, Quality, Regulatory, and other... ...performance dashboards, risk management frameworks, and trial... ...Good Clinical Practice (GCP) guidelines. Ensure...QualitySenior$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$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- Planet Pharma seeks a Senior Clinical Quality Assurance contractor to provide independent GCP leadership across the clinical portfolio, ensuring trial integrity, participant... ...with Clinical Development, Operations, Data Management, Biostatistics, Medical Writing, Regulatory...QualitySeniorFor contractors
$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$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$317k - $369k
...mission is to deliver significant clinical benefit to a wide range of... ...Medical Director, the Senior Medical Director will serve as... ...Clinical Operations, Program Management, Biostatistics and Data Management... ...program with attention to quality and scientific rigor. Lead...QualitySeniorHourly payFull timeContract workWork at officeLocal area3 days per week$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$230k - $281k
...to change that. We are a clinical‑stage biopharmaceutical company... ...Remix is seeking a Senior Director, Clinical Operations... ...budgets, enrollment, and quality in accordance with ICH GCP and applicable regulations... ..., and ongoing performance management; develop enrollment and retention...QualitySenior$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$138k - $190k
Job DescriptionRole Summary: The Senior Manager, Clinical Procurement is responsible for driving sourcing and procurement activities supporting... ...negotiate complex contracts, and ensure timely delivery of high-quality services from external suppliers. The individual will drive...QualitySeniorContract work$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- ...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
- 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
- Moderna Services, Inc. is seeking a Sr. Manager, Clinical Data Management to lead data management activities and vendor oversight for clinical... ..., Massachusetts. You will ensure milestones are met with quality and represent your function in cross-functional meetings. The...QualitySeniorRemote job
- Moderna Services, Inc. is seeking a Sr. Manager, Clinical Data Management in Cambridge, MA. Lead data management activities for studies and oversee CRO vendors, ensuring data quality and on-time deliverables for regulatory submissions. You will drive EDC setup, data review...QualitySeniorRemote job
- ...science. Role Description The Senior Director, Clinical Operations, will serve a... ...team, including mentoring and managing other Clin Ops team members... ..., Data Management, and Quality to ensure smooth launch and... ...regulations, in particular ICH/GCP guidelines. Demonstrated...QualitySeniorFull timeTemporary workFlexible hours
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