28 jobs voor clinical support manager gevonden

Support the development, design and optimization of clinical study documents, including study protocols, site guidelines, laboratory manuals, biomarker plan and other relevant clinical study documents;.Support budget management, vendor selection, and contract negotiations as needed;.

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

The position also includes researching and integrating cutting edge AI technologies to enhance clinical workflows.Key responsibilities.Develop Gen.

For an international company specialized in clinical trials, we're looking for a Med.Tech who will perform, review, and interpret a wide array of complex, esoteric, and routine chemical, hematological, coagulation, renal, lipid, and hormonal analyses.This position involves utilizing both manual and automated techniques, including microscopic methods, to deliver precise clinical laboratory analyses.

Your Key Responsibilities:

• Clinical Analysis: Conduct a variety of laboratory tests, including assays that diagnose complex disorders related to the cardiovascular, endocrine, hematological, hemostatic, thrombolytic, and renal systems.
• Data Evaluation: Analyze and interpret individual and related laboratory data, recognizing patterns and trends that indicate the significance of results.
• Integration with Clinical Trials: Collaborate closely with research teams to integrate analytical results with specific and varied clinical trial protocols.Evaluate the credibility, appropriateness, and accuracy of test results to determine subject eligibility for research programs.
• Quality Assurance: Ensure all laboratory procedures are conducted in compliance with established protocols and standards, maintaining high levels of accuracy and reliability.
• Administrative Support: Assist with administrative duties as requested by laboratory management, contributing to the smooth operation of the laboratory.
• Collaboration: Work effectively within a multidisciplinary team, contributing to collective goals and ensuring a cooperative and supportive work environment.

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.

Provide an inclusive work environment that ensures professional growth and development of team members through active training and development plans, coaching, and performance feedback processes (e.g., 1:1 meetings, skip level meetings)..

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.

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

Huisartsen, patiënten, bedrijven)..Je.Je.bent het aanspreekpunt van stafleden, artsen, clinical fellows, stagiairs voor al hun administratieve vragen. Verleg grenzen als coördinerend management assistant.Binnen.

Managing and coaching R&D services buyer, cultivating teamwork and excellence..

.Support GMP activities at the decentralized point of care manufacturing sites as part of tech transfers and clinical manufacturing, including equipment qualification, production training, aseptic process validation, process qualification runs, operational readiness..

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.

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.

Inventories, orders and distributes office supplies.Sorts and distributes incoming mail, correspondence and other printed material.

.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..

Support Vendor & platform selection and assist with writing platform selection documentation (RFI/RFP).Support ITS business domain owner Research, Scrum master and ITS Delivery lead in managing the PI Planning, and ITS budget.

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.

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.

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

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..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..

Mission Within Customer Project Coordination team, you are attached to Project Support Office for IBA Clinical.You will be the link between supply chain and Proton therapy project managers.

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..

.Establish key stakeholder relationships with internal stakeholders (Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Planning).

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

Ben jij ook een grensverlegger?Verleg grenzen als Data Platform Software DeveloperIn UZ Leuven bundelen dagelijks bijna 10.000 gedreven medewerkers hun expertise om kwalitatieve patiëntenzorg aan te bieden.Binnen UZ Leuven is IT van strategisch belang.