Manager, Clinical Quality Lead
hace 1 semana
.Johnson & Johnson is seeking a Manager, Clinical Quality Lead to provide Clinical quality oversight in support of the Laminar MedTech business. This position is based in Irvine, CA, or an alternative J&J site in the US. Monthly travel will be required for those not local to Irvine, CA.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.The Manager, Clinical Quality Lead works to support the R&D Quality objective and strategy in leading all aspects of a robust GxP Quality Management System to enable a diverse portfolio of medical device products and services.This individual serves as the clinical quality point of contact to support Licensing & Acquisition activities, integration, risk assessment, mitigations, remediation, inspections, and provide guidance on compliance-related activities within the business unit in Good Clinical Practice (GCP, ISO), as well as other applicable external regulations/requirements, and internal JNJ procedures.Key Responsibilities Lead Remediation & Integration: The Manager, Clinical Quality Lead will plan and lead clinical quality and integration activities to ensure effective execution of new product development, lifecycle management, supplier management, and provide overall clinical quality oversight.Portfolio Oversight: Develops and leads proactive risk management strategies in coordination with Clinical R&D business partners to address and lead the risk mitigation including preventative actions, training, and communications.Compliance Assessments / Audits: Ensure adequacy of failure investigation plans and supervises action plans / CAPAs to closure. May conduct Clinical audits of sponsor oversight, Clinical investigator sites, Clinical vendors, or Clinical processes.Inspections: Prepares the team and hosts regulatory inspections with Clinical scope. Partners with Regulatory Compliance to develop and align to inspection strategies, including preparation, execution, and resolution activities for Health Authority Inspections.Team Leadership, Cross-Functional Collaborations & Execution: Collaborate with the Quality Head, Quality Assurance, and other quality functions to develop and implement an effective GCP quality program.Qualifications Education: University/Bachelors (BA/BS) or equivalent degree required; concentration in Scientific or Business field is beneficial.Experience & Skills Required:Six to eight (6-8) years of Clinical research or Clinical quality related experience.Experience in a medium- to large scale, life sciences organization
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Clinical Quality Compliance Lead
hace 7 meses
Madrid, España ICON A tiempo completoAs a Clinical Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be responsible for streamlining the strategic integration of the quality and training function as key factors for the successful execution of clinical trials. **What you will be...
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Freelance Lead Clinical Data Manager
hace 3 días
Madrid, España Warman O'Brien A tiempo completoA Freelance Lead Clinical Data Manager is required for an initial 6 month contract with a global CRO. **WHAT YOU WILL BE DOING** - Lead studies as the Lead Clinical Data Manager; liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues Develop and/or review case report forms (CRFs) within an EDC system and...
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Clinical Quality Manager
hace 7 meses
Madrid, España ICON A tiempo completoAs a Clinical Quality Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Under the guidance of the Regional Director, Clinical Quality Management, the Clinical Quality Manager oversees all CQM activities in the respective country/cluster. The role requires the ability...
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Clinical Trials Manager Lead
hace 2 semanas
Madrid, Madrid, España Clinirx A tiempo completoSenior Clinical Project ManagerAbout the Role:Clinirx is seeking an experienced Clinical Trial Project Manager to manage and deliver assigned clinical studies within timelines and budgets in compliance with Good Clinical Practices and all Global, National and Local Regulations.Key Responsibilities:Lead project planning, implementation, control, and...
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Clinical Research Lead
hace 2 semanas
Madrid, Madrid, España Ora A tiempo completoAbout OraOra is a leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research to bring new products and therapies to market. With over 45 years of experience, our expert teams have helped earn more than 85 new product approvals.The Role: Lead Clinical Research AssociateAs a Lead Clinical Research...
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Clinical Trial Manager
hace 4 días
Madrid, España Worldwide Clinical Trials A tiempo completo**Requisition Number** **6115** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...
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Clinical Writer Team Lead
hace 3 semanas
Madrid, Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completoAbout the RoleWe are seeking an experienced Clinical Writer Team Lead to join our team at Syneos Health.As a key member of our Clinical Development department, you will be responsible for leading medical writing activities and mentoring junior team members.This is an exciting opportunity to work with a dynamic team and contribute to the development of...
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Clinical Trial Manager Ii
hace 2 días
Madrid, España Syneos Health Clinical A tiempo completo**Description** **Clinical Trial Manager II, Real World & Late phase studies** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and...
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Clinical Trial Manager I-ii Madrid. Sponsor
hace 1 día
Madrid, España Syneos Health Clinical A tiempo completo**Clinical Trial Manager I-II Madrid. Sponsor dedicated.** **-** **(**22004074**)** **Description** **Clinical Trial Manager II** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around...
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Senior Clinical Quality Operations Manager
hace 1 semana
Madrid, Madrid, España Empresa Reconocida A tiempo completoAbout the Role"Empresa Reconocida" is seeking a highly skilled Clinical Quality Operations Manager to provide strategic leadership and direction for our clinical quality operations team. The ideal candidate will have a strong background in clinical research and quality assurance, with experience in managing complex projects and teams.This role will be...
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Senior Global Project Manager II
hace 1 semana
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completoCompany OverviewSyneos Health is a leading fully integrated biopharmaceutical solutions organization, accelerating customer success by translating unique clinical, medical affairs and commercial insights into outcomes.Job SummaryWe are seeking an experienced Senior Global Project Manager II to lead our clinical study management efforts in Spain. The...
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Clinical Team Lead
hace 7 meses
Madrid, España TFS HealthScience A tiempo completoOverview: **International Clinical Team Lead - Clinical Trial Lead - Senior Project Manager** TFS HealthScience is excited to be expanding our SRS ** **team and we are looking for an experienced, highly motivated **Clinical Trial Lead **who shares our vision of providing clinical research excellence. Our **SRS** team is a highly experienced international...
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Senior Clinical Project Lead
hace 3 semanas
Madrid, Madrid, España Syneos Health A tiempo completoAbout Syneos HealthWe are a leading biopharmaceutical solutions organization accelerating customer success. Our unique clinical, medical affairs, and commercial insights translate into outcomes addressing modern market realities.Job OverviewAs Senior Clinical Project Lead at Syneos Health, you will oversee interdisciplinary clinical research studies,...
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Sr Clinical Trial Manager
hace 2 días
Madrid, España Syneos Health Clinical A tiempo completo**Sr Clinical Trial Manager - Real World & Late Phase - EMEA Based** **-** **(**22003167**)** **Description** **Senior Clinical Trial Manager - dedicated to RWE and Late Phase studies (EMEA based)** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which...
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Medical Writing Lead
hace 2 semanas
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completoLead Medical Writer Position OverviewWe are seeking a highly skilled and experienced Lead Medical Writer to join our team at Syneos Health, a leading biopharmaceutical solutions organization. As a Lead Medical Writer, you will play a crucial role in developing and managing medical writing projects, collaborating with cross-functional teams, and ensuring the...
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Clinical Project Manager Lead
hace 2 semanas
Madrid, Madrid, España Syneos Health, Inc. A tiempo completoAbout Syneos HealthSyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success by translating insights into outcomes. Our Clinical Development model puts the customer and patient at the center of everything we do, simplifying and streamlining our work to make us easier to work with and for.We are agile, driven to...
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Lead Clinical Research Associate
hace 1 mes
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Cdc Clinical Quality
hace 6 meses
Madrid, España Novo Nordisk A tiempo completoCDC Clinical Quality & Training Manager **Category**:Quality**Location**:Madrid, Comunidad de Madrid, ES- Are you passionate about Clinical Trials and looking for a challenge in a Leadership Team?- Do you want to be part of our Clinical Development Centre (CDC) team, integrated by Spain and Portugal?- - The position would be based in Spain.**The...
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Global Clinical Trial Manager Ii
hace 7 meses
Madrid, España Syneos Health Clinical A tiempo completo**Description** **Clinical Trial Manager II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...
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Clinical Operations Manager
hace 1 mes
Madrid, España Pharmiweb A tiempo completoClinical Operations Manager Madrid Madrid, Community of Madrid, ES Are you a seasoned clinical research professional ready to lead and oversee ground breaking studies in cardiology and ALS?I am seeking dynamic and experienced Clinical Operations Managers to join my client a leading Global CRO and drive the success of global trials across Europe and...