Quality Lead For Clinical Operations Emea
il y a 4 jours
Quality Lead for Clinical Operations EMEA (RE-34355166) Belgium Position: Quality Lead for Clinical Operations (freelance or payroll consultancy) Overview: We are seeking a dynamic and experienced Quality Lead for Clinical Operations to join our team. This role is pivotal in ensuring the highest standards of quality and compliance in all our clinical trials and related research activities. The successful candidate will be at the forefront of driving quality initiatives and maintaining rigorous oversight across various clinical programs. Key Responsibilities: Quality Leadership: Serve as the primary quality contact for a range of clinical studies including sponsored research, non-interventional studies, and early access programs. Act as the quality liaison for Global Medical Affairs, ensuring alignment and compliance with quality standards. Lead and support continuous improvement projects aimed at enhancing clinical quality. Provide expert QA input into projects such as audit strategies, regulatory implementations, and procedural reviews. Develop and drive risk-based internal audit plans to ensure proactive quality management. Regulatory Compliance: Stay abreast of new regulations and industry guidelines (e.G., ICH E6 R3) and assess their impact on clinical operations. Ensure all clinical trials adhere to relevant regulations and guidelines, maintaining the highest standards of compliance. Quality Oversight: Implement and oversee quality metrics and trends, sharing insights and best practices for continuous improvement. Coordinate the investigation of trial quality events, defining corrective and preventive actions as necessary. Manage the Serious Breach Process and provide support for unblinded investigations. Skills and Competencies: Extensive experience in Good Clinical Practices (GCP) and clinical quality management. Proven track record in quality oversight for various clinical research programs. Strong background in continuous improvement methodologies. In-depth understanding of clinical trial regulations and ICH guidelines. Excellent leadership skills with the ability to educate and motivate clinical teams on quality issues. Strong relationship-building capabilities with both internal and external stakeholders. Ability to thrive in a fast-paced, dynamic biotech environment with challenging deadlines. Qualifications: A degree in Life Sciences or a related field. Fluent in English with excellent communication skills. Why Join Us: This is an exclusive opportunity for individuals passionate about clinical quality and compliance. Whether you prefer to work as a freelance consultant or as part of our payroll team, you will play a crucial role in ensuring the success and integrity of our clinical operations. Join us and make a significant impact in a rapidly growing biotech company. Contact Gilles Carpentier (g.Carpentier(at)realstaffing.Com) #J-18808-Ljbffr
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Clinical Research Lead
il y a 7 jours
Bruxelles, Région de Bruxelles, Belgique Advanced Clinical Temps pleinCompany OverviewAdvanced Clinical is a global clinical development organization that provides comprehensive services for biopharmaceutical and medical device organizations. Our mission is to deliver exceptional clinical experiences for our clients.We have global experience in over 50 countries, and we are committed to improving lives touched by clinical...
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Senior Clinical Research Associate
il y a 4 semaines
Bruxelles, Région de Bruxelles, Belgique Advanced Clinical Temps pleinAdvanced Clinical is recruiting for an inspiring biotechnology company focused on rare diseases. You will be an experienced CRA looking for their next step into complex disease areas. In collaboration with our client, the senior Research associate (SCRA) is responsible for developing and maintaining the relationship with the site. The Senior Clinical...
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Senior Clinical Research Associate
il y a 3 semaines
Bruxelles, Région de Bruxelles, Belgique Advanced Clinical Temps pleinAdvanced Clinical is recruiting for an inspiring biotechnology company focused on rare diseases. You will be an experienced CRA looking for their next step into complex disease areas.In collaboration with our client, the senior Research associate (SCRA) is responsible for developing and maintaining the relationship with the site. The Senior Clinical Research...
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Senior Clinical Research Associate
il y a 3 semaines
Bruxelles, Région de Bruxelles, Belgique Advanced Clinical Temps pleinAdvanced Clinical is recruiting for an inspiring biotechnology company focused on rare diseases. You will be an experienced CRA looking for their next step into complex disease areas.In collaboration with our client, the Senior Clinical Research Associate (SCRA) is responsible for developing and maintaining the relationship with the site. The SCRA is the...
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il y a 22 heures
Bruxelles, Région de Bruxelles, Belgique Advanced Clinical Temps plein**About Us**Advanced Clinical is a leading provider of clinical development services for biopharmaceutical and medical device companies. Our global experience spans over 50 countries, and we are dedicated to improving lives through clinical research.Job Summary:The Senior Clinical Research Associate will be responsible for developing and maintaining...
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il y a 3 semaines
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il y a 4 semaines
Bruxelles, Région de Bruxelles, Belgique Planet Pharma Travail à distance Freelance Temps pleinPlanet Pharma are working alongside a Leading Biotech who are seeking a GenAI and Data Analytics Operations Lead to join their global team and have operational oversight of the SME Leads in the company. Our client is a global biotech company based in Belgium that pride themselves on an exciting innovative environment that will ensure continuous company...
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il y a 4 semaines
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il y a 4 jours
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il y a 4 semaines
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il y a 3 semaines
Bruxelles, Région de Bruxelles, Belgique Johnson & Johnson Temps pleinJob Description - Clinical Research Leader (2506232901W)Clinical Research Leader - 2506232901WDescriptionAt 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....
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il y a 2 jours
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il y a 7 jours
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il y a 3 semaines
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il y a 6 jours
Bruxelles, Région de Bruxelles, Belgique Advanced Clinical Temps pleinKey ResponsibilitiesThe Senior Clinical Research Associate will be responsible for developing and maintaining relationships with clinical sites. They will serve as the single point of contact for assigned sites throughout the study lifecycle, from feasibility to post-study timelines.The role involves performing site management and monitoring activities,...
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il y a 7 jours
Bruxelles, Région de Bruxelles, Belgique Planet Pharma Temps pleinOur client, a leading biotechnology company in Europe, is looking for a Clinical Sourcing Lead to join the team. Within this role you will be responsible for the below: Oversee and manage the Sourcing Management team within the assigned franchise area, leading all sourcing activities. Promote alignment and consistency across teams by mentoring team...
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il y a 4 semaines
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AI and Data Analytics Operations Lead
il y a 1 semaine
Bruxelles, Région de Bruxelles, Belgique Planet Pharma Temps pleinPlanet Pharma are working alongside a Leading Biotech who are seeking a GenAI and Data Analytics Operations Lead to join their global team and have operational oversight of the SME Leads in the company. Our client is a global biotech company based in Belgium that pride themselves on an exciting innovative environment that will ensure continuous company...
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il y a 6 jours
Bruxelles, Région de Bruxelles, Belgique Planet Pharma Temps pleinJob OverviewPlanet Pharma, a leading biotechnology company in Europe, is seeking a Clinical Sourcing Lead to join its team. As a key member of the organization, you will oversee and manage the Sourcing Management team within assigned franchise areas, ensuring seamless sourcing activities.Main ResponsibilitiesLead all sourcing activities within designated...