Quality Lead for Clinical Operations EMEA
il y a 1 semaine
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-
Senior Clinical Research Associate
il y a 2 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...
-
Senior Clinical Research Associate
il y a 1 semaine
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...
-
Senior Clinical Research Associate
il y a 1 semaine
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...
-
EMEA IT Supply Chain Leader
il y a 6 jours
Bruxelles, Région de Bruxelles, Belgique CareerWise Recruitment Temps pleinKey Responsibilities:The EMEA IT Supply Chain Leader will be responsible for:Developing the IT strategy for the EMEA supply chain functions, including MES roadmap, aligning with business goals and objectives.Translating strategy into action: executing relevant projects/initiatives aligned with organizational goals and leading cross-functional teams, ensuring...
-
Director of IT Operations EMEA
il y a 6 jours
Bruxelles, Région de Bruxelles, Belgique CareerWise Recruitment Temps pleinAbout This Role:The EMEA IT Supply Chain Leader will play a crucial role in optimizing processes, enhancing efficiencies, and implementing innovative IT solutions to support the organization's Integrated Supply Chain and Manufacturing Environment.Main Responsibilities:Developing the IT strategy for the EMEA supply chain functions, including MES roadmap,...
-
Digital Technology Lead, AI for Clinical Development
il y a 1 semaine
Bruxelles, Région de Bruxelles, Belgique UCB S.A. Temps pleinMake your mark for patientsTo strengthen UCB Digital Technology department, based at the HQ, in Brussels, Belgium we are looking for a talented individual to fill the position of: Digital Technology Lead, AI for Clinical Development.As Digital Technology Lead, AI for Clinical Development, you drive global strategy for technology and AI adoption in the UCB...
-
Manager - Contractor Quality Operations
il y a 2 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...
-
Senior Director, Clinical Project Leadership
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique Planet Pharma Temps pleinLevel of Role: Senior Director Industry: Pharmaceutical / Biotechnology Location: Remote / Belgium Planet Pharma are working alongside a Global Biotech who are seeking a Senior Director to join and lead their team in their clinical operations and development. This company have grown by 75% in recent years, have seen their share price grow by 461% in five...
-
Solutions Quality Lead
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique Proclinical Staffing Temps pleinProclinical is seeking a Solutions Quality Lead to contribute to quality directions and insights that protect patients and ensure sustainable compliance. This role involves supporting inspection readiness activities and maintaining quality standards in research and clinical operations. The focus is on compliance with Good Laboratory Practice (GLP), Good...
-
Clinical Research Leader
il y a 1 semaine
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....
-
Manager/Sr Manager Clinical Operations
il y a 3 semaines
Bruxelles, Région de Bruxelles, Belgique Thermo Fisher Scientific Temps pleinWork ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to...
-
Senior Clinical Programmer
il y a 6 jours
Bruxelles, Région de Bruxelles, Belgique Simbec-Orion Group Temps pleinOur MissionOur passion for improving patients' lives motivates us to apply our skills, experience and knowledge to advance medicine.We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.The RoleWe are looking for a Senior Clinical Programmer to join our Biometrics Department where you will be...
-
AI and Data Analytics Operations Lead
il y a 2 semaines
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...
-
Research Associate
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique Advanced Clinical Temps pleinAdvanced Clinical is recruiting for an inspiring biotechnology company focused on rare diseases. 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 Associate is the main point of contact for the site. In addition, the Senior Clinical...
-
Senior Project manager
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique Planet Pharma Temps pleinLevel of Role: Senior Director Industry: Pharmaceutical / Biotechnology Location: Remote / Belgium Planet Pharma are working alongside a Global Biotech who are seeking a Senior Director to join and lead their team in their clinical operations and development. They are true innovators and support patients within varying therapeutic areas and mostly...
-
IT Leader
il y a 3 semaines
Bruxelles, Région de Bruxelles, Belgique CareerWise Recruitment Temps pleinAn IT Leader – for the Global Integrated Supply Chain (EMEA) required by CareerWise Recruitment for our client. Preferred location: Brussels or Dublin. Remote opportunity. The Integrated Supply Chain (ISC) IT Leader for the EMEA region is a strategic leadership position responsible for overseeing and managing all Information Technology initiatives and...
-
IT Leader
il y a 2 semaines
Bruxelles, Région de Bruxelles, Belgique CareerWise Recruitment Temps pleinAn IT Leader – for the Global Integrated Supply Chain (EMEA) required by CareerWise Recruitment for our client. Preferred location: Brussels or Dublin. Remote opportunity. The Integrated Supply Chain (ISC) IT Leader for the EMEA region is a strategic leadership position responsible for overseeing and managing all Information Technology initiatives and...
-
IT Leader
il y a 7 jours
Bruxelles, Région de Bruxelles, Belgique CareerWise Recruitment Temps pleinAn IT Leader – for the Global Integrated Supply Chain (EMEA) required by CareerWise Recruitment for our client. Preferred location: Brussels or Dublin. Remote opportunity. The Integrated Supply Chain (ISC) IT Leader for the EMEA region is a strategic leadership position responsible for overseeing and managing all Information Technology initiatives and...
-
AI and Data Analytics Operations Lead
il y a 2 semaines
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...
-
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...
