Clinical Operations Excellence Lead
il y a 2 semaines
ROLES AND RESPONSIBILITIES:
- Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documents
- Identify and drive continuous improvement of processes and systems within Global Clinical Operations organization
- Ensure quality risk management principles are integrated in all Global Clinical Operations processes and systems in order to support compliance and ensure inspection readiness throughout
- Drive the investigations and development of CAPA plans related to process-level non-compliances, audit and inspection findings, within the Global Clinical Operations organization
- Actively contribute to a feedback culture on non-compliance, CAPA, inspection and audit findings. Identify opportunities to share knowledge and expertise
- Actively participate in defining and monitoring compliance and quality metrics to ensure compliance oversight in Global Clinical Operations processes and projects
- Identify and implement leading edge technologies and methodologies to enable quality by design of clinical study activities
- Active member of the Global Clinical Operations leadership team to ensure alignment across functions and regular review of the inspection readiness status
- Lead and/or contribute to cross-functional and/or cross-company initiatives aiming to increase quality and compliance, while decreasing rework
- Ensure alignment with the QA organization
- Act as interface between Global Clinical Operations and stakeholder organizations/functions in clinical development
- Foster co-creative working relations with partnering organizations such as QA, BIS, Clinical Development, GPS, GRA
SKILLS AND COMPETENCIES:
- Extensive experience of GCP/Pharmacovigilance quality management systems, applicable regulatory rules and guidelines, medical terminology, clinical trials, and drug development
- Excellent interpersonal negotiation and leadership skills
- Strong written and verbal communication skills, acting globally in a culturally-diverse dynamic team
- Ability to act independently and effectively prioritize
- Root Cause Analysis, CAPA Development and Risk Management methodology expertise
EDUCATION, EXPERIENCE AND QUALIFICATION:
- Bachelor’s degree or University degree - medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
- Minimum of 10 years of experience in Clinical and/or Pharmacovigilance Quality Management
- Working knowledge of the relationship and regulatory obligations of pharmaceutical/biotech companies and CROs
- Global Strategic Drug Development experience
-
Clinical Operations Development Lead
il y a 3 semaines
Gent, Flandre, Belgique argenx SE Temps pleinClinical Operations Development Lead page is loadedClinical Operations Development LeadApply locations Gent, Belgium time type Full time posted on Posted 30+ Days Ago job requisition id REQ-3022The Clinical Operations Development Lead (CODL) is a key member of the Indication Development Team (IDT), overseeing clinical activities for a specific therapeutic...
-
Clinical Operations Development Lead
il y a 2 semaines
Gent, Belgique MindCapture Temps pleinCLINICAL OPERATIONS DEVELOPMENT LEAD - Biotech- Ghent & remoteWHAT IS OFFERED The Clinical Operations Development Lead plays a critical role in ensuring the success of clinical trials and the development of new therapeutic assets, coordinating efforts across various functions and stakeholders to drive effective clinical development strategies. Next to a...
-
Franchise Clinical Operations Development Lead
il y a 2 semaines
Gent, Belgique MindCapture Temps pleinFRANCHISE CLINICAL OPERATIONS DEVELOPMENT LEAD - Biotech- GhentWHAT IS OFFERED Franchise Clinical Operations Development Lead plays a critical role in overseeing the operational path for all indications within a franchise. Functioning as a line manager, and ensuring consistency to synergy across different indication teams. The Franchise Clinical Operations...
-
Clinical Operations Lead
il y a 7 jours
Gent, Belgique MRM Health Temps plein**Clinical Operations Lead** **Company Overview** **Position description** MRM Health is looking for a Clinical Operations Lead to join and reinforce its Clinical Development Team in Ghent, Belgium, and translate pre-clinical and translational research into novel and differentiating products and, ultimately, breakthrough microbial strategies for the...
-
Clinical Operations Development Lead
il y a 2 semaines
Gent, Belgique Argenx Temps pleinDue to the exponential growth of argenx worldwide, we are currently looking for several _Clinical Operations Development Leads (CODL) _to strengthen the Global Clinical Trial Operations team. Ideally, location would be based in Belgium._ - The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a...
-
Clinical Operations Development Lead
il y a 3 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Clinical Operations Development Lead, East FlandersClient: ArgenxLocation:Job Category: OtherEU work permit required: YesJob Reference: 3ede1a58f0d8Job Views: 10Posted: 03.03.2025Expiry Date: 17.04.2025Job Description:The Clinical Operations Development Lead is responsible for the oversight of the clinical related...
-
Clinical Operations Development Lead
il y a 4 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Clinical Operations Development Lead, GhentClient: ArgenxLocation: Ghent, BelgiumJob Category: OtherEU work permit required: YesJob Reference: 3ede1a58f0d8Job Views: 8Posted: 15.02.2025Expiry Date: 01.04.2025Job Description:The Clinical Operations Development Lead is responsible for the oversight of the clinical...
-
Clinical Trial Manager
il y a 4 semaines
Gent, Flandre, Belgique argenx Temps pleinTo support the expansion of our Global Clinical Trial Operations team, we are currently looking for a Clinical Trial Manager.The Clinical Trial Manager (CTM) operates cross-functionally with global accountability for operational deliverables of clinical studies from Final Protocol Concept Sheet to Clinical Study Report (CSR) and applicable results...
-
Global Director of Clinical Operations
il y a 1 semaine
Gent, Belgique Sequana Medical NV Temps pleinGeneral Description Under the Direction of the Chief Medical Officer, the Director of Clinical Operations will be leading the execution of our current and future clinical trials assigned to the director, which includes the management of the clinical department in collaboration with the other management functions in the clinical department. Key...
-
Clinical Trial Manager
il y a 2 semaines
Gent, Belgique Proclinical Temps pleinProclinical is recruiting a Clinical Project Manager/Clinical Trial Manager for a Mid-size CRO. This role is on a permanent basis and is located in Belgium. **Responsibilities**: - Contribute to the strategy or plan for clinical development. - In the allocated clinical study, proactively identify and address problems to the head of trial operations, and/or...
-
Clinical Trial Manager
il y a 3 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinAs we are growing, we are currently looking for a Clinical Trial Manager (CTM).The CTM is responsible for all operational aspects of the assigned clinical studies from monitoring initiation till closure of the studies. The successful candidate will have clinical trial operational experience in phase I, II and III drug development phases and is an operational...
-
Global Director of Clinical Operations
il y a 1 semaine
Gent, Belgique Sequana Medical NV Temps plein**General Description** Under the Direction of the Chief Medical Officer, the Director of Clinical Operations will be leading the execution of our current and future clinical trials assigned to the director, which includes the management of the clinical department in collaboration with the other management functions in the clinical department. **Key...
-
Operations Expert
il y a 3 semaines
Gent, Flandre, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Operations Expert / Lab Technician, Oost-VlaanderenClient:Randstad Professionals BelgiumLocation:Oost-VlaanderenJob Category:OtherEU work permit required:YesJob Reference:e3262acb5df1Job Views:2Posted:06.03.2025Expiry Date:20.04.2025Job Description:As CAR-T Operations Expert, you will be part of the manufacturing...
-
Car-t Operations Support Lead
il y a 1 semaine
Gent, Belgique Legend Biotech EU Temps plein**Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **ROLE OVERVIEW** The CAR-T Operations...
-
Clinical Scientist
il y a 2 semaines
Gent, Belgique Argenx Temps pleinFor the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional team...
-
Clinical Scientist
il y a 1 semaine
Gent, Belgique Argenx Temps pleinFor the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...
-
Clinical Scientist
il y a 1 semaine
Gent, Belgique Argenx Temps pleinFor the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...
-
Car-t Operations Manager
il y a 1 semaine
Gent, Belgique Legend Biotech EU Temps plein**Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview** You will be...
-
Operations Expert
il y a 2 semaines
Gent, Belgique Legend Biotech EU Temps plein**Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **ROLE OVERVIEW** As **CAR-T Operations...
-
Biostatistics Lead
il y a 2 semaines
Gent, Belgique Argenx Temps pleinWe are looking for a lead biostatistician, to join the team of biostatistics as part of Quantitative Sciences. The position will be located in any of our affiliations in Ghent (Belgium) or Boston (US). Your role: - You are a statistical leader in the cross-functional development team of one compound/indication - You contribute with statistical expertise to...