Senior Site Manager Ed&cp
Il y a 6 mois
Johnson & Johnson is currently seeking a **Senior Site Manager **ED&CP **to your our team in Beerse, Belgium.
A Senior Site Manager ED&CP may contribute to process improvement, training and mentoring of other Site Managers.
**Principal Responsibilities**:
Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
2. Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.
3. Attends/participates in investigator meetings as needed.
4. Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies. Responsible for the implementation of ARBM (Analytical Risk Based Monitoring) model at the site level when applicable. Monitors study progress at site using study specific systems and available reports/dashboards.
5. Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at site and sponsor level.
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
7. Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
8. In collaboration with Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensures strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried accounted and returned as applicable including maintenance of accurate and complete documentation.
9. Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed.
10. Ensures accuracy, validity and completeness of data collected at trial sites. Ensures appropriate measures are in place for maintenance of the blind when applicable
11. Ensures that all Adverse Events (AE)/Serious Adverse Events (SAE)/Product Quality Complaints (PQC) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents. Maintains complete, accurate and timely data and essential documents in systems utilized for trial management.
12. Maintains complete, accurate and timely data and essential documents in systems utilized for trial management
13. Fully documents trial related activities with respect to study monitoring. Writes visit reports and address follow-up letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
14. Reviews investigator site File for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
15. Collaborates with TM for documenting and communicating site/study progress and issues to trial central team.
16. Attends regularly scheduled team meetings and trainings.
17. Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops sufficient therapeutic area and early development knowledge to support roles and responsibilities. Works across therapeutic areas dependent upon ED&CP business needs.
18. Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g., On Site Quality Monitoring Visit (OSQMV).
19. Prepares trial sites for close out, conduct final close out visit.
20. May review and manage site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations.
21. May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
22. Tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of site payments
23. Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in Early Development and/or Clinical Pharmacology.
24. Coordinates site level lessons learned activities.
26. May be assigned as a coach and mentor to less experienced SMs, as needed and may perform accompan
-
Senior Site Manager
Il y a 5 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinWe are looking for a driven Senior Site Manager (Clinical Research Associate) to serve as the primary contact point between the Sponsor and the Investigational Site for trials in Late Development (phase 1b-2-3). As Senior Site Manager, you will be assigned to trial sites to ensure compliance with the clinical trial protocol, company Standard Operating...
-
Senior Clinical Research Associate
Il y a 6 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinWe are looking for a driven Senior Site Manager (Senior Clinical Research Associate) to serve as the primary contact point between the Sponsor and the Investigational Site for trials in Late Development (phase 1b-2-3). As Senior Site Manager, you will be assigned to trial sites to ensure compliance with the clinical trial protocol, company Standard Operating...
-
Senior Site Manager
il y a 6 jours
Antwerpen, Belgique Johnson & Johnson Temps pleinWe are looking for a driven Senior Site Manager (Clinical Research Associate) to serve as the primary contact point between the Sponsor and the Investigational Site for trials in Late Development (phase 1b-2-3). As Senior Site Manager, you will be assigned to trial sites to ensure compliance with the clinical trial protocol, company Standard Operating...
-
Site Manager
Il y a 5 mois
Antwerpen, Belgique Quanta Temps pleinSite Manager - Energy and Renewables - Antwerp, Belgium -12-Month Contract Are you looking for your next short-term contract Site Manager assignment? Our client, a global leader in crane rental services, is looking to onboard a talented UK based Offshore Crane operator for an ongoing offshore construction project. With state-of-the-art equipment and value...
-
Site manager
il y a 1 mois
Antwerpen, Belgique CTRL-F Temps pleinFor our market leader in road construction, we are looking for a Site Manager specifically for asphalt. Your working day starts at 7 am and you will mainly work in the region of East Flanders and Antwerp. As a real people manager, you are responsible for the day-to-day management and supervision of the site teams (1 to 2 shifts). You take...
-
Site Manager
Il y a 6 mois
Antwerpen, Belgique Tec NV Temps plein**Site Manager**: Voor een boeiende, langdurige opdracht regio Antwerpen zoeken wij een ervaren Elektrische Site Manager? Sector Electrical, Other Location 2000 Antwerpen , Antwerpen **Functieomschrijving**: Als Site manager sta je in voor de dagelijkse coördinatie op de werf waar je samen met je team instaat voor het inrichten, onderhouden en...
-
Site Manager
Il y a 6 mois
Antwerpen, Belgique Cegelec Industry Temps pleinActemium België geeft advies over, ontwerpt, realiseert en ondersteunt industriële processen. We bieden ook service en opleidingen. Onze activiteiten: elektriciteit & instrumentatie, IT/ICT, automatisering en mechanics & piping. Het is onze missie om klanten te helpen met het verbeteren van hun concurrentievoordeel en industriële prestaties. Vandaag...
-
Site Manager
Il y a 5 mois
Antwerpen, Belgique CTRL-F Temps pleinFor our market leader in road construction, we are looking for a Site Manager specifically for asphalt.Your working day starts at 7 am and you will mainly work in the region of East Flanders and Antwerp.As a real people manager, you are responsible for the day-to-day management and supervision of the site teams (1 to 2 shifts).You take responsibility for...
-
Senior Manager Primary Container Lcm
Il y a 5 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJanssen Supply Group, LLC., a member of Johnson & Johnson's Family of Companies, is recruiting for a **Senior Manager Primary Container Lifecycle Management! **This role is within our Small Molecule Drug Product Primary Container & Device Team, Manufacturing Sciences & Technology. This position will be located at the Janssen Supply Chain (JSC) site in...
-
Project & Site Manager
Il y a 5 mois
Antwerpen, Belgique Squarehub Temps pleinBen je klaar om een cruciale rol op je te nemen in een dynamische start-up die de ontwerp - en installatie van voorzieningen in residentiële gebouwen revolutioneert? Bao Living is op zoek naar een uitzonderlijke Project - en Site Manager om uitmuntendheid in projectuitvoering te bevorderen. Met jouw sterke organisatorische vaardigheden zorg je ervoor dat...
-
(Senior) Manager Process Science Modeling
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinThe (Senior) Manager Process Science Modeling, positioned in the Innovation and Technology Deployment organization of Manufacturing Science and Technology (MSAT), leads a distributed team in the modeling of real manufacturing processes. We support all sites, platforms and modalities - all over the globe. Our mission is to make Johnson & Johnson's...
-
Senior Accountant
Il y a 5 mois
Antwerpen, Belgique Conessence Temps plein**Bedrijfsinformatie**: Voor een bedrijf actief in de** industriële reiniging**, met kantoor in de **Haven van Antwerpen**, ben ik op zoek naar een **Senior Accountant** **Taken**: - Je doet de** coördinatie van de maandafsluiting** en **jaarafsluiting **van de **diverse entiteiten**: - Je voert **controles **uit op de **boekhouding**, **correctheid...
-
Senior Manager, EHS Excellence Emea
il y a 2 jours
Antwerpen, Belgique Kenvue Temps pleinDescription Kenvue is currently recruiting for: **Senior Manager, EHS Excellence EMEA** Role is based in Prague, Czech Republic or Antwerp, Belgium **Who we are** At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including Neutrogena, Aveeno,...
-
Senior Manager Account Management
Il y a 3 mois
Antwerpen, Belgique PA Solutions Temps plein**Senior Manager Account Management**: PA Solutions is looking for a Senior Manager Account Management for our Life Science BU. **Who we are**: Process Automation Solutions is one of the leading manufacturer-independent suppliers of complete automation solutions for the process and manufacturing industries. The company currently employs more than 1,900...
-
Site Management Assistant
Il y a 6 mois
Antwerpen, Belgique Cegelec Industry Temps pleinActemium België geeft advies over, ontwerpt, realiseert en ondersteunt industriële processen. We bieden ook service en opleidingen. Onze activiteiten: elektriciteit & instrumentatie, IT/ICT, automatisering en mechanics & piping. Het is onze missie om klanten te helpen met het verbeteren van hun concurrentievoordeel en industriële prestaties. Vandaag...
-
Senior HR Business Partner
Il y a 7 mois
Antwerpen, Belgique Amazon Transport Belgium SRL - J44 Temps pleinHave significant HR experience as a senior leader, ideally within a high volume, fast paced and customer focussed environment - Have the ability to develop effective working relationships with employees at all levels - Have a proven hands-on attitude, be flexible and adaptable. - Demonstrate the ability to motivate others and influence work behaviours -...
-
Senior Manager Qc Microbiology
Il y a 6 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJohnson & Johnson Innovative Medicine is currently looking for a Senior Manager Quality Control Microbiology at the Beerse site in Belgium. At J&J, everyone is committed to making a difference in people's lives and to push the boundaries of what science and innovation can achieve. The values that guide our decision-making are spelled out in Our Credo. Put...
-
Senior Project Manager
Il y a 2 mois
Antwerpen, Belgique CBRE Temps plein**Senior Project Manager** **Job ID** - 185114**Posted** - 09-Oct-2024**Service line** - GWS Segment**Role type** - Full-time**Areas of Interest** Facilities Management, Project Management **Location(s)** Antwerp - Antwerpen - Belgium **Senior Project Manager** As Senior Project Manager, you will act as liaison between the client and 3rd party...
-
Managing Consultant
Il y a 3 mois
Antwerpen, Belgique ERM Group Temps pleinERM is seeking a dynamic, results-driven, and seasoned Managing Consultant to join our Liability Portfolio Management and Remediation (LPMR) team in Antwerp (Belgium). In this pivotal role, you will oversee a portfolio of significant investigation, construction, and remediation projects across Belgium for a key ERM client. This is a prime opportunity for a...
-
Senior Manager Account Management
Il y a 5 mois
Antwerpen, Belgique PA Solutions Temps plein**Senior Manager Account Management**: PA Solutions is looking for a Senior Manager Account Management. Are you curious about this role and ready for a new adventure? Read further below! **Your responsibilities**: - As Senior Manager Account Management you locally lead and manage all sales operations for existing customers and accounts. - You represent our...
