Clinical Quality Manager

hace 4 semanas

Madrid, España ICON A tiempo completo

As 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 to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In

addition, the CQMs support audits, inspections as well as Quality Control and local training activities.

**What you will be doing**:

- Regulations & Processes
- Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes)
- In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
- Local expert for any quality-related local processes.
- Training
- Local expert for any quality-related local processes.
- In close cooperation with local country operations management, identifies / coordinates local training needs.
- Quality Control (QC) Activities
- In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.
- In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.
- Audits & Inspections
- Primary local point of contact for MRL Quality Assurance and Regulatory Agencies.
- Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.- In cooperation with local country operations and/or headquarters, performs root-causeanalysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.- Quality / Compliance / Privacy Issue Escalation
- Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
- Escalates significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.
- Clinical Supplies GCP Investigations
- Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
- Supplier Qualification
- Leads local supplier qualifications and re-qualifications of locally selected suppliers and supports solving of quality issues with locally selected suppliers.
- Supports the Quality Management System (QMS) assessment for local supplier qualifications and re-qualifications.
- MRL Compliance & Privacy Steward
- Supports implementation of divisional compliance/privacy initiatives and reporting at the local level.

Global / Regional Key Initiatives / Projects

**You are**:

- Bachelor's Degree or equivalent in relevant health care area.
- A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred.
- Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.
- Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
- Demonstrated experience in leading cross-functional teams.
- Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.
- Ideally, experience in managing audits and inspections.
- Ideally, experience in coordinating and delivering training sessions.
- Superior oral and written communication and leadership skills in an international environment.
- Excellent project management, organizational and prioritization skills.
- Excellent teamwork skills, including conflict resolution expertise and discretion.
- Ability to analyze, interpret, and solve complex problems.
- Ability to think strategically, objectively and with creativity and innovation.
- Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.

**Why ICON?**

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbe

  • Cdc Clinical Quality

    hace 1 mes

    Madrid, España Novo Nordisk A tiempo completo

    CDC 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...

  • Clinical Trial Manager Ii

    hace 2 meses

    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...

  • Clinical Quality Compliance Lead

    hace 2 horas

    Madrid, España ICON A tiempo completo

    As 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...

  • Global Clinical Trial Manager Ii

    hace 4 días

    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...

  • Global Clinical Trial Manager Homebased Madrid

    hace 1 mes

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Global Clinical Trial Manager **HOMEBASED MADRID ** - Sponsor Dedicated** 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 the world and build the career...

  • Global Clinical Trial Manager Homebased Barcelona

    hace 1 mes

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II **BARCELONA ** - Sponsor Dedicated** 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 the world and build the career you’ve...

  • Global Clinical Trial Manager Homebased uk

    hace 2 días

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II **BARCELONA ** - Sponsor Dedicated** 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 the world and build the career you’ve...

  • Sponsor Dedicated Clinical Trial Manager Ii

    hace 2 meses

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor Dedicated Clinical Trial Manager II / Sr CTM - Home Based in SPAIN** Experience in the management of **global/multi-country** studies and different types of vendors is required. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique...

  • Sponsor Dedicated Clinical Trial Manager Ii

    hace 1 mes

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor dedicated Clinical Trial Manager II / Sr CTM - Spain or UK Home-Based** **Experience in the management of global/multi-country studies and different types of vendors is required.** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a...

  • Clinical Trial Manager Ii Madrid. Sponsor Dedicated

    hace 2 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...

  • Sponsor Dedicated Clinical Trial Manager Ii/ Sr

    hace 4 días

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor dedicated Clinical Trial Manager II/ Sr CTM - Home Based in Spain** Experience in the management of **global/multi-country** studies and different types of vendors is required. Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product...

  • Clinical Trial Manager Ii Homebased Spain

    hace 1 mes

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II **SPAIN ** - Sponsor Dedicated** 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 the world and build the career you’ve dreamed...

  • Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm

    hace 2 meses

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based Spain** Experience in the management of global/multi-country studies is required Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly...

  • Senior Clinical Data Manager

    hace 2 semanas

    Madrid, España Precisionscientia A tiempo completo

    .Position Summary:The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will...

  • Senior Clinical Data Manager

    hace 2 semanas

    Madrid, España Precision For Medicine A tiempo completo

    .Position Summary:The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will...

  • Clinical Project Manager

    hace 1 semana

    Madrid, España PSI CRO A tiempo completo

    Job DescriptionTake your career to the next level and lead challenging full-service global clinical research projects, managing the full scope of responsibilities and getting hands-on involvement in every aspect of the study.Your responsibilities will include:Management of global, multi-center clinical research projects in a variety of therapeutic...

  • Clinical Project Manager

    hace 1 semana

    Madrid, España PSI CRO A tiempo completo

    **Company Description** PSI is an award-winning full-service CRO, bringing together more than 2,700 dynamic and knowledgeable individuals working to help impact the future of medicine in more than 60 countries around the world. We support pharmaceutical, biotechnology, and medical device companies with the services needed to perform clinical trials of new...

  • Clinical Project Manager

    hace 7 días

    Madrid, España Psi Cro A tiempo completo

    PSI is an award-winning full-service CRO, bringing together more than 2,700 dynamic and knowledgeable individuals working to help impact the future of medicine in more than 60 countries around the world. We support pharmaceutical, biotechnology, and medical device companies with the services needed to perform clinical trials of new medicines. Our work...

  • Clinical Project Manager

    hace 5 días

    Madrid, España Psi Cro A tiempo completo

    PSI is an award-winning full-service CRO, bringing together more than 2,700 dynamic and knowledgeable individuals working to help impact the future of medicine in more than 60 countries around the world. We support pharmaceutical, biotechnology, and medical device companies with the services needed to perform clinical trials of new medicines. Our work...

  • Clinical Trial Manager

    hace 3 semanas

    Madrid, España Al Solutions A tiempo completo

    Clinical Trial Manager - Start-up CRO - Spain.Taylor Young is working with a Start-up CRO that is looking for a Clinical Trial Manager to join a highly experienced clinical operations team in Spain.My client has very strong core values which results in a great work environment and very happy staff!This role is working remotely in Poland. This is a unique...