19 jobs voor clinical project manager 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..

Review study documents, contract and budgets .Collaborate with Project Managers, Research teams and international stakeholders on the clinical studies and research programs.

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.

• Lead Equipment management process
• Be the SME on that process for the entire unit
• Train the Asset owner from equipment purchase to equipment installed.
• Be responsible for metrology aspect: Ensure mapping and reports delivered by the External vendors are compliant with the specificities defined by the Lab.
• Ensure at least 1 internal Audit/year.
• Be the responsible person for Clinical and Medical Controlled Document (CMCD) management: handle revisions, ensure CMCD compliance with the companies regulations and ISO17025 requirements.
• Active member of Lab Quality meetings: act as strong advisor and lead project.
• Ensure Audit and Inspection readiness.
• Review study protocols and provide feasibility assessments on ability to perform laboratory requirements and procedures & ensure clinical trials are conducted according to the protocol requirement, objectives and timelines.Direct collaboration with the Laboratory team to execute and coordinate the qualitative actions within the framework ISO 17025.
• Responsible for maintaining/demanding ISO17025 accreditation/certification of our Safety Laboratory.
• Assures accurate collection and processing of biological specimens to assure quality of analytical data.
• Integrate and monitor quality indicators (key performance indicator = KPI), handle non-conformities and claims as well as corrective and preventive actions.Follow-up of all discrepancies and close collaboration with Manager(s).
• Define KPI's for management review.

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

Algemene logistieke ondersteuninguitschrijven van project team meetingrapportenbestellen van studiemateriaalarchiveringingeven van onderzoeksdataopvolging van labo onderzoeksresultaten

Main responsibilitiesOwnership of account management for existing and new customers.To include the first point of contact for support inquiries, enable technical implementation of software by efficient communication with different stakeholders (physicians, MRI techs, IT).Continuous development of relationships with new and existing customers, through communication, project management & technical support, and quality control to assure clarity of clinical results for the correct interpretation by radiologists, neurologists or other physicians for use with CT and MRI data.Pre and post sales support.

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.

De financiële dienst van UZ Leuven bestaat uit 4 afdelingen, m.n.Algemene Boekhouding, Kas en Bankbeheer, Kredietbeheer en Financiële Coördinatie van het Clinical Trial Center (klinische studies)..

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.

Lead, coach, and motivate the sales team by setting clear objectives and monitoring performance .Lead, coach, and motivate the Marketing, Instrument, and Product Management teams .

Proactively ensure logistics for internal events (such as team building activities, business meetings,.) and celebrations (seniority, weddings, long term sicknesses,..Manage group registrations for congresses and teaching courses;.

.Field epidemiologist with interest insocial sciences.

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.

Je werkt management ondersteunend voor het diensthoofd en de stafleden (zoals onderwijsondersteuning, notuleren bij vergaderingen, kredietbeheer enz).Je zorgt voor de administratieve ondersteuning bij de organisatie van congressen en examens..

.Je bent het aanspreekpunt van stafleden, artsen, clinical fellows, stagiairs voor al hun administratieve vragen.

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..

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