29 jobs voor clinical support manager gevonden

The CDS role involves implementing upgrade and new projects, working in a team of various technical and project management specialists.It will include conducting workflow and integration analyses, configuration of the PACS, RIS and Speech solutions, delivering training as well as go live support.

Legal Support: Oversee legal aspects of clinical trials, partnerships, and collaborations to ensure compliance with international and local regulations..Contracts Management: Draft, review, and negotiate agreements, including clinical trial agreements, partnership contracts, and service provider arrangements..

You can become our new Contract Coordinator!

Mission & responsibilities:

The main responsibility of the contract coordinator is to provide a legally correct contract. You support the Business Development and Procurement team in the set-up and review of clinical research related agreements (master service agreements, stand-alone service agreements and work orders).

Of course you don't have to do this on your own!

Content wise you get help from the departments concerned to set-up and review the clinical research related agreements.Our legal department makes sure that everything is correct from a legal point of view.

• You coordinate the internal review of contractual issues and liaise with Sales, Legal and Finance departments, Proposal Development, and the Operational Managers.
• You manage the contract database and all associated files, including the administration, tracking and follow-up.
• You give support to Operations in the set-up and review of contract amendments.

Our ITM team collaborates closelywith the Infectious Diseases Unit of the University Hospital of Antwerp.The Travel Medicine Research Unit focuses on surveillance, observational and interventional studies and mainly randomized clinical trials in travelers within their national and international network.

Ben jij ook een grensverlegger?.Verleg grenzen als clinical support manager op de dienst tandheelkunde.

For a major medical company specialised in clinical research we are looking for a Facility Coordinator.

Provides general Facilities and site support to the Brussels Lab location, through the performance of assigned tasks related to facilities services and building maintenance.

Essential Functions

• Supports day-to-day Facilities operations at the GCL Brussels location, including but not limited to: day-to-day Facilities operations
• Acts as a back-up for the Receptionist
• Undertakes daily building checks and inspections and addresses issues
• Anticipates and responds to building or equipment maintenance tasks, including the completion of work requests, scheduled routine maintenance, and preventive maintenance and repairs
• Supervises contractors and the execution of planned maintenance and contracted services
• Assists with the ordering of supplies and management of inventories
• Performs document storage in line with SOP requirements
• Ensures that Facilities policies and procedures are followed
• Liaises with suppliers, contractors and Facilities management
• Acts as a point of contact for other departments
• Responds to facility-related emergencies as assigned
• Participates in the on-call rotational schedule for REES
• Supports Facilities project work where required
• Provides support with health and safety matters where needed

Managing administrative tasks in cleanrooms on computerized systems, including user management, audit trail extraction, periodic file deletions, backups, and ensuring compliance with Good Documentation Practices..Handling the export of run data to a centralized location upon operational request..

GMP cleanroom.You will oversee various units within process operations, including component preparation, manufacturing support, fill & finish, and cryopreservation, ensuring compliance with c.

Managing daily production planning and routine production flow..Supporting manufacturing investigations and creating/revising operational procedures, including work instructions and batch records..

.Managing administrative tasks in cleanrooms on computerized systems, including user management, audit trail extraction, periodic file deletions, backups, and ensuring compliance with Good Documentation Practices..

The candidate will also liaise withEUAf.ME, CLAR and APAC regulatory staff to support other global registration and product maintenanceactivities where appropriate.The candidate will liaise with VMRA Regulatory Chemistry Manufacturing andControl (CMC), Laboratory Sciences, Global Biological Research, Global Therapeutic Research, CommercialDevelopment, Global Manufacturing, Project Management, and other partner groups to drive regulatoryactivities consistent with approved Company objectives.Key responsibilities:Assemble renewal and variation dossiers for biological veterinary products and coordinate/support subsequent responses to Authority questions.

Leveranciers voor praktijkmanagers, Clinical Directors en support staff..Samen met onze business analist verwerk je analyses met betrekking tot de inkoop en maakt verbetervoorstellen..

Opstellen van werkinstructies voor toegewezen processen.Naleven van afgesproken doorlooptijden van verschillende processtappen en de klant informeren indien nodig Analyseren van trends bij problemen en definiëren van verbetervoorstellen Bijdragen aan nieuwe projecten binnen het team en het distributiecentrum, in lijn met de behoeften van de klant Nauw contact onderhouden en duurzame relaties opbouwen met verschillende stakeholders, waaronder klanten zoals Clinical Supply Chain, Trial management, Study leads, Ops support van het distributiecentrum, system support, etc

Key Responsibilities:.Project Coordination: Lead and coordinate ongoing diagnostic research projects, ensuring smooth execution and impactful results..

The TMF Records Specialist is a member of the core trial team and is responsible to provide operational expertise to the core trial team, oversees the implementation of the (Trial Master File) TMF strategy for the trial and supports the core trial team in all aspects of TMF management and in inspections or audits.

The TMF Records Specialist provides and maintains oversight and guidance related to TMF activities throughout the course of the trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times.

The TMF Records Specialist closely collaborates with the core trial team to create, implement and maintain the list of trial specific expected records.This includes the identification of all relevant trial level records required to reconstruct the trial, independent of owner or system hosting the record.

In this role you are responsible for the planning, tracking, formal QC and filing of all TMF trial level records according to internal and external standards and also to initiate the close out of the TMF.Besides you will share the status to the core trial team on the completeness, quality and timeliness of the TMF during the entire life cycle of the trial.

Ensuring compliance with financial legislation and staying informed about updates..Collaborating with colleagues both locally and internationally, as well as external accounting firms..

.Lead and supervise various units within the process, such as component preparation, production support activities, process, filling & finishing, and cryopreservation..

Lead and supervise various units within the process, such as component preparation, production support activities, process, filling & finishing, and cryopreservation..Build strong collaborative relationships with various departments, including Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Procurement & Supply Chain/Warehouse..

Component preparation manufacturing, manufacturing support operations, process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to c.GMP requirements..

Component preparation manufacturing, manufacturing support operations, process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to c.GMP requirements..

Provides support to writing and revising SOPs and associated documents (incl.batch records, work files, checklists, procedures) related to routine Production documentation..

Participate in Quality Assurance activities: documentation update, internal & external audits, qualifications and validations, complaints handling and deviations ..Quality assurance:..

Provides support to writing and revising SOPs and associated documents (incl.batch records, work files, checklists, procedures) related to routine Production documentation..

You will lead and perform multiple units within the CAR T process operations (i.e.component preparation manufacturing, manufacturing support operations, CAR T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to requirements.

Capsule filling machine), but also globally used web applications, Clinical Trial Management Systems, complex Manufacturing Execution Systems, SAP systems, medical devices, etc… 

Equipment Maintenance: Keep equipment running smoothly by following instructions, troubleshooting issues, and coordinating repairs..Process Optimization: Contribute to process optimization, introduce new products, procedures, and equipment in GMP areas..

Equipment Maintenance: Keep equipment running smoothly by following instructions, troubleshooting issues, and coordinating repairs..Process Optimization: Contribute to process optimization, introduce new products, procedures, and equipment in GMP areas..

Cleanroom Manufacturing: Operate daily in a Grade A/B/C/D cleanroom environment, maintaining equipment and facility cleanliness..Aseptic Processing: Manufacture clinical and commercial grade ATMPs through aseptic manual processes, including cell isolation, selection, activation, transduction, culture, fill and finish, and cryopreservation..