37 jobs voor clinical support manager gevonden

Regulatory Affairs personnel (in house).Coordinating efforts with international division staff to.resolve product/clinical issues involving international customers.

Position: Change Management, Communications & Engagement Support Intern

Goal of assignment:

DATA4YOU is a multi-year (2021 - 2025) strategic program delivering the state-of-the-art J&J clinical

data review platform leveraging AI and ML to facilitate the work of key personas managing clinical trials.

This program comes with a high investment and a high expectation toward cost & time savings,

operational and organizational benefits.

One of the pillars in the DATA4YOU program is investing in Organizational Change Management and

Communications as the user community is very diverse.For this work stream we are looking for

additional support to set the team up for success.

Change Management, Communications & Engagement Support Intern role specific responsibilities:

We are looking for someone who will be joining the Program Change Management &Communications

team.This person will be given several deliverables to coordinate and

help deliver within the set project timelines.Examples of assignments:

- Building communications materials such as presentations that are visually appealing

- Building creative supportive materials such as e-flyers, posters, animated banners supporting

announcements

- Organize small events

Collaborate with Project Managers, Research teams and international stakeholders on the clinical studies and research programs.Contribute to scientific/ medical training & scientific contents to raise awareness on Oncology research .

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.

New reporting tools, Databricks functionality AI/ML evaluation and implementation Documentation Management / Computer System Validation Support.

Word jij ook een grensverlegger?Ontdek onze vacatures op uzleuven.be/jobsJobomschrijvingVerleg grenzen als clinical support manager op de dienst tandheelkundeBinnen de dienst tandheelkunde van UZ Leuven worden drie basisopdrachten verenigd: patiëntenzorg, opleiding en onderzoek.Het organiseren van de volledige undergraduate en Ma.

Our client is specialised in developing advanced medical devices, diagnostic tools, and telehealth services that enhance patient care and improve clinical outcomes.Jobomschrijving.

To develop medical communication and continuing medical education (CME) via all kinds of formats e.g.manuscripts, meeting presentations and reports, congress highlights and programmes, clinical cases, and other creative educational solutions..

A dynamic role that mixes event planning, office management, and creative teamwork.I'm looking for a motivated junior/medior who wants to gain experience, make an impact, and grow.

Client Details

Our client is specialised in developing advanced medical devices, diagnostic tools, and telehealth services that enhance patient care and improve clinical outcomes

Description

• Hands-On Office Support: Tackle a variety of tasks from managing emails, preparing meeting rooms, and arranging catering, to supporting office supplies and building needs.
• Administrative Support: Agendamanagement for the Directors, fleet administration, and car registration
• Travel & Guest Arrangements: Coordinate travel plans for our team, including booking hotels, arranging cabs, and making guests feel welcome when they visit.
• Event Planning with a Twist: Organise and host monthly celebrations, team-building activities, and the annual Christmas party!You'll bring your creativity to the table, making each event unique and fun.
• Internal Communications: Work closely with different teams to keep everyone updated and engaged with internal news and initiatives.
• Onboarding & Team Support: Help our new hires settle in by ensuring they have all their essentials, from laptops to phones, and assist with account setups for a seamless start.

Be The Right Hand to The CMO, Professor Jean-Louis Vanoverschelde:

• Provide seamless support in a fast paced environment
• Take ownership of responsibilities, efficiently managing time to meet deadlines
• You are the first person of contact for the CMO and hence need to utilize your excellent written and spoken language skills to engage with different stakeholders
• You collaborate with The Communications Department in order to draft diverse documents whilst maintaining the CMO's and Saint Jean's style and values
• You have full access to the CMO's e-mails and carte blanche for his agenda, you coordinate all his calls, meetings and events including the logistics, agenda/presentation and minutes
• You maintain a helicopter view of the CMO's activities in order to plan ahead and hence deliver on time
• You support projects by planning, gathering data, preparing all documents including presentations as well as following-up so due dates are met
• You propose and implement new procedures to ensure a continual efficient running
• You are responsible for the CMO's office supplies including the choice of suppliers

Huisartsen, patiënten, bedrijven)..Je beheert de agenda van het medisch diensthoofd, bewaakt zijn beschikbaarheid en telefonische permanentie..opvolging voorschriften, attesten, oka plannning, …).

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

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

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.

Candidates will be required to know the desk side environment and tools.The candidate will be located at the customer site. Key areas of responsibility Respond to IT related Requests and Incident calls in Service Now Correctly create Tech Hub visit tickets, track incidents and IMAC tickets in a timely and accurately manner in Service Now PC (Desktops/Laptops) Hardware and Software Troubleshooting Portable devices.IPhone, IPad, Windows Tablet.Diagnose printer hardware and software, and other peripheral device failures and implement solutions Provide installation and upgrade services of supported hardware and software Some hardware support experience required e.g., installing memory/disk drives Supporting the call center with "on the fly" information relating to open cases

Candidates will be required to know the desk side environment and tools.The candidate will be located at the customer site. Key areas of responsibility Respond to IT related Requests and Incident calls in Service Now Correctly create Tech Hub visit tickets, track incidents and IMAC tickets in a timely and accurately manner in Service Now PC (Desktops/Laptops) Hardware and Software Troubleshooting Portable devices.IPhone, IPad, Windows Tablet.Diagnose printer hardware and software, and other peripheral device failures and implement solutions Provide installation and upgrade services of supported hardware and software Some hardware support experience required e.g., installing memory/disk drives Supporting the call center with "on the fly" information relating to open cases

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

.Creates work schedules and assignments, ensures policies and procedures are accurate, trains staff and assesses competence, participates in staff hiring, corrective action, evaluation, and career progression..

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.

The Program

The Johnson & Johnson Supply Chain Internship offers you the opportunity to get a first glimpse of

your potential future career and to apply your academic knowledge in a real-life supply chain context.

Our internship is a great way to get noticed within the world of J&J!

As an intern you will be part of a team and get to experience the daily challenges we face in the Johnson

& Johnson Supply Chain.The intern will be assigned to any of the following business areas:

- Advanced Therapies (Beerse or Gent)

Project examples: Optimize logistics flows, support operational readiness of new CAR-T EMEA

production sites, etc.

- Deliver Distribution & Warehousing (Beerse, Diegem or Courcelles)

Project examples: Support development of CO2/Sustainability calculation in order frequency

and transportation, Develop site strategic roadmap, Inbound/Outbound process

improvements, etc.

- Innovative Medicine Supply Chain.Chemical Production (Geel)

Project examples: Digitization projects, Research on equivalency of different reactors and on

performance of materials towards the chemical processes, Data analytics for process

optimization, etc.

- Innovative Medicine Supply Chain.Pharmaceutical Production (Beerse)

Project examples: Conduct Root Cause Problem Solving, Initiate business cases and

Implement process improvement actions, including Kaizen.

- Clinical Supply Chain (Beerse)

Project examples: Data analytics for process optimization, Sustainability & Innovation

projects, Support implementation of new production infrastructure etc.

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

You continuously improve the software team processes to ensure they cover the relevant functional safety standards..You work autonomously with support of your team lead..

.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:..