30 jobs voor clinical support manager gevonden

What will your main tasks be?

• Prepare and update clinical evaluation plans and reports (CERs) for Class III medical devices;
• Liaise with internal and external stakeholders to ensure timely completion of CERs;
• Prepare and update PMS plans, periodic safety update reports (PSURs), post-market clinical follow-up (PMCF) plans and reports, and summaries of safety and clinical performance (SSCPs) for Class III medical devices;
• Conduct clinical literature and vigilance database searches;
• Conduct PMCF studies (e.g.surveys) and collaborate with the Product Management Department or support consultants conducting such studies;
• Implement scientifically and statistically sound methods into study plans and data analyses;
• Participate in the design, management and reporting of clinical investigations as required;
• Liaise with Sales, Marketing and QA Departments to ensure PMS activities are conducted under regulatory supervision;
• Ensure relevant CE marking documents, including product technical files, are complete and up to date;
• Perform vigilance activities as required.

You will also have to ensure that the organisation consistently meets legal obligations, focusing on:

• Compliance with the Medical Device Regulation (MDR) for Class III medical devices;
• Clinical evaluation requirements under the MDR;
• Post-market surveillance (PMS) requirements under the MDR.

Bedrijfsprofiel:

Join a leading innovator in the dental industry as a Clinical Regulatory Affairs Specialist.Do you want to advance your career with a globally recognized company known for its high-quality products, and already have some experience in clinical research and medical writing?Then this role is perfect for you!

Assist experts of other development areas in the company (e.g.pre clinical, clinical, project management) to estimate the required API quantities and required quality to fulfil the Global Project Plans.

The CPP Summer Interns will be involved in various activities to support Research and Development in areas ranging from preclinical to early/late stage clinical development, including:* Clinical Pharmacology and Medical literature review* Data analysis of PK, biomarker, preclinical and/or clinical data, trial design, etc.* PK and PD model building and analyses* Development of computer programs or state of the art quantitative methodologies (e.g., population PK/PD, quantitative systems pharmacology [QSP]) within the modeling and simulation framework* Model based meta analysis (MBMA), advanced data visualization (e.g., RShiny), and machine learning applications integrating publicly available and in house data* Diseases areas of immunology, oncology, neuroscience, pulmonary hypertension, or cardiovascular and metabolic diseasesBedrijfsprofiel:VOOR JANSSEN PHARMACEUTICA, ONDERDEEL VAN JOHNSON EN JOHNSON CAMPUS BEERSE, ZIJN WIJ OP ZOEK NAAR:

Attending study team calls;.Primary point of contact for study teams and investigational sites;.

For a major medical company specialised in clinical research we are looking for an English speaking inverstigator service assistant.You will be responsible for the overall performance, education and training of the sites to ensure that protocols are completed accurately and on time.The Investigator Services Assistant provides support to investigator sites, monitors, and other departments within the labs through communication of information, training sites and documentation of services pertaining to clinical trials.

Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of

people everywhere.Career opportunities within Johnson & Johnson companies may provide you with an ideal

setting to build your leadership experience, express your passion, and touch the world.

Janssen Research & Development aims to transform patients' lives by discovering and developing innovative

solutions to address the most important medical needs of our time.Within the Janssen R&D Finance

organization,

Global Development group together with around¿ 9000¿ internal and external colleagues from across the globe, we

manage clinical sites¿ and the execution of clinical trials, lead the operational delivery of clinical R&D trials and

programs, transform data into information to build knowledge, deliver the medical affairs portfolio & pre-approval

access and implement a great variety of¿ clinical operations processes and systems.

Key responsibilities of the role include:

- Supporting Affiliate funding process including Quarter close Journal Entry posting

- Supporting Flex process with reconciliation and Journal Entry posting

- Time compliance reports ¿ sharing the reports with the finance team.

- Travel&Entertainment expense reporting for Global Development organization

- Headcount management on ad-hoc basis for Global Development

- Creation of new cost centers, Non-Development projects codes and overall master data transactions

- Assisting reporting activities.

Bedrijfsprofiel:

VOOR JANSSEN PHARMACEUTICA, ONDERDEEL VAN JOHNSON EN JOHNSON CAMPUS BEERSE, ZIJN WIJ OP ZOEK NAAR:

Ben jij ook een grensverlegger?.Verleg grenzen als clinical support manager op de dienst tandheelkunde Binnen de dienst tandheelkunde van UZ Leuven worden drie basisopdrachten verenigd: patiëntenzorg, opleiding en onderzoek.

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 Bedrijfsprofiel:Select Projects maakt deel uit van de Select groep, een verzameling HR bedrijven die de mens voorop zetten want Quality is Performance by Genuine People.

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.

Fulfilment of targets (sales, margin, price realization, market share, NPS).Identifies and builds strong and lasting business relationships with all key decision makers (clinical, technical, administrative/economic), key opinion leaders and society board members in all accounts.

Seek management guidance on complex issues.Drive continuous improvementCompany:The QA Investigator is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply.

Electronical Lab Notebook, sample management system, …).Contributes to the writing of technical documents like reports, user guides, guidances, etc.Performs double check within the team.Shows good communication skills/teamworking skills.

Medpace Laboratories is een centraal labo ter ondersteuning klinische studies pharmaceutische industrie.Wij zijn gevestigd industriepark Heverlee en zoeken enthousiaste Administratief medewerker ter ondersteuning van project management team.

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..

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..

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.

We, at Sanofi, are there beside people in need, as a health journey partner+100,000 employees, representing 142 nationalities90 countries where Sanofi is present, providing healthcare solutions in 170 countries69 manufacturing sites in 32 countries21 Research and Development sites comprising medicines, clinical research and vaccinesJobomschrijvingThe Manufacturing Science and Analytical Technology department (MSAT) represents the scientific backbone of the company that provides commercial support, process/method optimization (lifecycle management), technology transfer of new products and processes/methods and development of innovative, robust, and cost effective next generation processes/methods The focus of the MSAT Process Engineer Consultant is on the upstream cell culture part of the manufacturing process Starting from thorough scientific and technical knowledge, this role will contribute to (small scale) Technology Transfer activities aiming at introduction of new products and processes at the Sanofi Geel biopharmaceutical manufacturing site.Additionally, you will contribute to improvement initiatives of existing processes at the Sanofi Geel site and within the broader Sanofi network.

The Manufacturing Science and Analytical Technology department (MSAT) represents the scientific backbone of the company that provides commercial support, process/method optimization (lifecycle management), technology transfer of new products and processes/methods and development of innovative, robust, and cost effective next generation processes/methods..The focus of the MSAT Process Engineer Consultant is on the upstream cell culture part of the manufacturing process..

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..

Fixing equipment issues, improving processes, and introducing new products...Maintaining production areas, following procedures to produce clinical & commercial grade ATMPs, and testing batch samples for quality assurance.

.Maintaining production areas, following procedures to produce clinical & commercial grade ATMPs, and testing batch samples for quality assurance.fixing equipment issues, improving processes, and introducing new products..

Job duties will be performed within a team based environment, on an assigned production shift scheduleYou will work in the GMP Facility in Ghent and report to the Operational Manager, Europe.RESPONSIBILITIESThe Operations Supervisor will lead and supervise multiple units within the process operations (i.e.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.

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..

You will be responsible for the batch record review of a personalized cell therapy in support of both clinical and commercial requirements in a sterile c.GMP environment.

Client Details

The company is a global biotechnology company dedicated to treating and ultimately curing life-threatening diseases.Headquartered in Somerset, New Jersey, they develop advanced cell therapies across a broad range of technology platforms,

From their various locations around the world, they apply these innovative technologies to pursue the discovery of safe, effective and advanced therapies for patients worldwide.

The company is all about helping people in their fight against diseases with the ultimate goal of complete healing.

For the Zwijnaarde branch, the company is looking for a new Administrative Manager of Blood Samples to participate in their research.

Description

This is the duties of an Administrative Officer for Blood Samples:

• You are responsible for the preparation and updates of all documentation related to the blood samples.
• You are responsible for the production of production documents.
• You carry out quality checks on the blood samples.
• You carry out checks on the documents that release the blood samples.
• You are a communication link between various internal departments.
• You assist with audits if necessary.
• You will interact with other departments for batch record information and documentation issues.
• You take care of the status assessments and update the spreadsheets and reports.

As a laboratory technician, you are responsible for processing and analyzing blood samples, data imput and ensuring quality.BedrijfsomschrijvingThe company is a global biotechnology firm dedicated to treating, and one day curing, life threatening diseases.They are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T cell, T cell receptor (TCR T), and natural killer (NK) cell based immunotherapy.

Engage with authorities and coordinate audits as needed (internal/external audits).Review promotional material and clinical documentation.

Within these practices different roles are taken up by the Q&C engineers such as qualification and validation of equipment, production lines, cleaning, sterilization, utilities, software’s as well as business analysis, engineering, building, project management and so much more.Most of the Q'ers have a scientific background; often industrial engineers, bioengineers, biotechnologists, biomedical scientists, pharmacists, but historians, translators/interpreters, communication scientists, etc.

Analysis of immunohistochemically stained images, defining regions of interest in (tumor) tissue sections, qualitatively evaluate staining and overall assay performance, etc.) through the various phases of development under supervision of assay development scientist..Preparation of project related documentation (development and validation plan), including literature study..