8 jobs voor project manager clinical research gevonden

.Lead a cross functional team in executing clinical research projects..Manage projects within the agreed budget, ensuring customer expectations are met..Collaborate with various teams and vendors throughout the project lifecycle..

JobomschrijvingAls Clinical Research Specialist ondersteun je klinische onderzoeken binnen de Clinical R&D afdeling en onderhoud je sterke samenwerkingen binnen het bedrijf.Je bent verantwoordelijk voor de uitvoering van klinische studies, zorgt voor naleving van tijdslijnen en regelgeving, en werkt samen met verschillende interne en externe belanghebbenden..

Begeleiden van Clinical Research Associates (CRAs) en bijdragen aan de ontwikkeling van onderzoeksstrategieën..Ondersteunen van de naleving van protocollen en procedurele vereisten bij klinische proeflocaties..

These are mainly focused on GCP and are mostly site and study (including e.TMF and CSR) audits, or vendor qualification audits.Participate in the yearly vendor evaluation. Participate in additional team initiatives, like development of training material, providing training related to the quality management system and quality awareness, identify process improvement opportunities, foster a culture of quality, and provide advice / expertise on questions from colleagues (Gx.

Icometrix acts throughout the healthcare system from providers, payers and pharmaceutical industry, as our AI solutions support improved personalised medicine of neurological disorders.As such, icometrix’ studies team entails both icometrix’ specific evidence studies as well as services for strategic pharmaceutical partnerships and trials.  As scientific project manager, you will manage such studies, engage with key stakeholders and focus on generating impactful scientific evidence.

What will you do ?

• Coordinate clinical studies and trials towards generating optimal clinical and health economic evidence of the icometrix portfolio

• Boost our neuro-imaging services to support optimal engagement of radiologists, neurologists, or other physicians aligned with the evidence strategy of icometrix

• Take a pro-active lead in the evidence dissemination plan (including scientific writing)

• Manage milestones, deliverables, timelines, budget, and quality to allow optimal implementation of our imaging services and e.PRO services.

• Monitor progress, report and present study status, timelines, budget and quality of your deliverables to the Project Team, Management and Customer. 

• Lead study-specific decision-making, develop improvements for increasing study efficiencies and co-ordinate issue detection and resolution

• Coordination of external partners (sites, additional vendors, both sponsor related as icometrix related)

• GCP complaint delivery and assure optimal coordination and communication for optimal implementations

• Prepare and support potential audits and inspections

• Have a critical view on the study results and Reporting proactively to the Team Manager on critical study-related issues

• Monitor closely project related elements linked to data management, Risk assessment and execution, contribution for submission ethics committees

• Participate in the development and coaching of less experienced staff

As Operational Quality Manager (OQM) you are welcomed in a smaller, amiable, and enthusiastic
QA team where you will have day-to-day interaction with other QA experts in the field, such as other OQMs, Quality Compliance Managers, Auditors, …

As OQM, you will be an indispensable partner of the operational teams - specifically at our Clinical Pharmacology Unit (CPU) in Edegem - in the management of their part of the quality system.As such, you will gain insight into the different investigator site processes applicable for the conduct of clinical trials for pharma and biotech companies from start to finish.

Your responsibilities:

Your main responsibilities are the following:

• Collaborate with the assigned operational teams at CPU to improve quality and maintain high quality standards throughout the organization by:
  • Developing and maintaining operational quality (SOPs, WIs, CDs, and manuals and various guidance documents) and personnel documents
  • Leading the non-conformance management process by guiding the teams through the risk assessment of non-conformances, Root Cause Analyses and formulation of CAPA Plans or corrections
  • Supporting the teams by providing additional explanation on topics relating to quality documents/process improvements, development of trainings (e.Learnings, classroom trainings) together with the QA training department
  • Proposing changes to operational quality documents and associated training to improve the quality system
  • Initiating process improvements / efficiencies where needed
  • Supporting the teams in performing their daily work in a consistent and efficient way, by the creation of operational checklists, guidance documents, etc.
• As assigned, assist in the further development of the new SGS CR electronic Quality Management System.
• In general, participate in / facilitate cross-functional discussions and working groups related to any aspect of quality at the CPU, to create or optimize cross-functional procedures, or to look for efficiencies in processes, systems, and collaboration.

·.Collaborate with epidemiologists, data scientists, social scientists, communication experts, public health experts and governance experts.

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