Sr Local Trial Manager
Il y a 4 mois
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we, in France, are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”
**Janssen France is currently recruiting a Senior Local Trial Manager (M/F) to be based in Issy-les-Moulineaux on a permanent contract.**
**Position Summary**:
The Sr Local Trial Manager (LTM III) is responsible for local management of a clinical trial (or Medical Affairs
data generation activity) in a country or countries. The LTM III is the primary point of contact at a country
level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to
database lock and closeout activities as described in GCO procedural documents. The LTM III is responsible
for coordinating and leading the local trial team to deliver quality data and trial documents/records that are
compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good
Clinical Practice (GCP), and regulatory requirements.
The LTM III role actively leads or contributes to process improvement; training and mentoring of other LTM s
and Site Managers (SM).
Compared to LTM I and LTM II roles, an LTM III is often assigned to more complex protocols and can work
across Phase 1 - 3 studies in multiple therapeutic areas as needed to drive business needs.
The LTM III may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single
country as described in GCO procedural documents.
**Principal Responsibilities**:
- Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
- Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list.
- Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs.
- Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
- Maintains and updates trial management systems. Uses study tools and management reports available to analyze trial progress.
- Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
- May submit requests for vendor services and may support vendor selection.
- In certain situations, may assist in negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered -within budget. Adheres to finance reporting deliverables and timelines.
- Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
- Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
- Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed.
- Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
- Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent f
-
Clinical Trials Specialist
il y a 4 semaines
Issy-les-Moulineaux, Île-de-France Withings Temps pleinWithings is dedicated to becoming the trusted leader in clinical-grade smart health devices. As a prominent innovator in smart scales, our diverse product lineup includes connected scales, blood pressure monitors, sleep monitors, thermometers, and health/activity wearables.Our products empower a wide range of innovators in the healthcare sector to enhance...
-
Clinical Trials Specialist
il y a 4 semaines
Issy-les-Moulineaux, Île-de-France Withings Temps pleinWithings is dedicated to becoming the leading authority in clinical-grade smart health devices. As a frontrunner in innovative health technology, our extensive product range includes connected scales, blood pressure monitors, sleep tracking devices, thermometers, and health/activity wearables.Our products empower a diverse array of innovators in the...
-
Clinical Trials Specialist
il y a 4 semaines
Issy-les-Moulineaux, Île-de-France Withings Temps pleinWithings is dedicated to leading the way in clinical-grade smart health technology. As a prominent innovator in the realm of smart scales, our diverse product lineup encompasses connected scales, blood pressure monitors, sleep tracking devices, thermometers, and health/activity wearables.Our offerings empower a wide array of innovators in the healthcare...
-
Lead Clinical Site Manager
il y a 4 semaines
Issy-les-Moulineaux, Île-de-France Johnson & Johnson Temps pleinPosition OverviewA Lead Clinical Site Manager acts as the key liaison between the Sponsor and the Investigational Site.This role is dedicated to ensuring that trial sites are always prepared for inspections by adhering to the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and relevant regulations and...
-
Clinical Trial Assistant
Il y a 2 mois
Les Ulis, France IPSEN Temps plein**Title**: Clinical Trial Assistant **Company**: Ipsen Innovation (SAS) - Support the clinical project management and monitoring of clinical studies, including liaison with, monitors, CROs, drug vendors, central laboratories and other vendors for study related tasks. - Be an active member of the study team and take responsibilities for service provider...
-
Functional Manager Business Operations I
Il y a 3 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps pleinThe Functional Manager Business Operations I (FMBO I) is accountable for strategic and operational management of clinical trials EC&HA submission through the management of a dedicated submission team. You will be responsible for overseeing resources at departmental level, providing managers and directors with the information they need to make...
-
Lead Clinical Site Coordinator
il y a 4 semaines
Issy-les-Moulineaux, Île-de-France Johnson & Johnson Temps pleinPosition Overview: A Clinical Site Coordinator plays a pivotal role as the main liaison between the Sponsor and the Investigational Site. This position is essential for ensuring that the site remains inspection-ready by adhering to the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and relevant regulations...
-
Senior Site Manager
Il y a 4 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps pleinVous voulez contribuer à un projet de grande envergure et avoir un impact sur le monde qui vous entoure ? Intégrer Janssen, la division pharmaceutique du Groupe Johnson & Johnson, leader mondial dans le domaine de la santé (126500 collaborateurs dans le monde, 265 entreprises présentes dans 60 pays), c'est participer au développement de solutions...
-
Clinical Submission Specialist
Il y a 3 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps pleinFor more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the...
-
Clinical Trial Associate
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinPlease send your CV in English ! **Purpose of the position** - Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies - Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting...
-
Clinical Trial Associate
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Purpose of the position** - Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies - Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking - Responsible for...
-
Clinical Research Associate
Il y a 4 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps pleinJohnson & Johnson is the largest and most broadly-based healthcare company in the world. We’re producing life-changing breakthroughs every day and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track...
-
Sr Manager, Clients Nationaux
Il y a 3 mois
Issy-les-Moulineaux, France Coca-Cola Europacific Partners Temps pleinVous recherchez de nouveaux challenges professionnels au sein de CCEP ? Nous avons une opportunité pour vous ! xx Coca-Cola Europacific Partners (CCEP) est l’une des entreprises leader dans les biens de consommation et le plus grand embouteilleur indépendant au monde. Avec une équipe dédiée de 33 200 personnes, au service de nos clients dans 29...
-
Clinical Research Associate
il y a 7 jours
Issy-les-Moulineaux, Île-de-France Withings Temps pleinAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our Clinical Operations team at Withings. As a Clinical Research Associate, you will play a critical role in the design, development, and execution of clinical trials for our innovative connected health devices.Key ResponsibilitiesParticipate in the design phase of clinical...
-
Clinical Research Associate
il y a 1 semaine
Issy-les-Moulineaux, Île-de-France Withings Temps pleinAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our Clinical Operations team at Withings. As a Clinical Research Associate, you will play a critical role in the design, development, and execution of clinical trials.Key ResponsibilitiesParticipate in the design phase of clinical investigations by becoming an expert on the...
-
Clinical Research Associate
il y a 2 semaines
Issy-les-Moulineaux, Île-de-France Withings Temps pleinAbout WithingsWithings is a leading innovator in clinical-grade smart health devices, dedicated to providing accurate, real-world data to innovators in the healthcare industry.Job SummaryWe are seeking a Clinical Research Associate to join our Clinical Operations team, responsible for participating in the design phase of clinical investigations, assisting in...
-
Clinical Research Associate
il y a 2 semaines
Issy-les-Moulineaux, Île-de-France Withings Temps pleinAbout WithingsWithings is a leading innovator in clinical-grade smart health devices, dedicated to providing accurate, real-world data to innovators in the healthcare industry.Job SummaryWe are seeking a Clinical Research Associate to join our Clinical Operations team, responsible for participating in the design phase of clinical investigations, assisting in...
-
Alternance Attaché de Recherche Clinique
Il y a 3 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps plein**Alternance Attaché de Recherche Clinique (ARC)** **_MISSION _** - Assurer le rôle d’Attaché de Recherche Clinique (SM, pour Site Manager) pour des études Late Phase ou des Etudes de Développement Précoce (équipe ED&CP - Early Development & Clinical Pharmacology), incluant la sélection des centres investigateurs, la mise en place de l’étude...
-
Gestionnaire de Paie
Il y a 4 mois
Challes-les-Eaux, France SR Conseil Temps pleinGroupe SR Conseil (19 bureaux, 550 collaborateurs) est une société pluri-professionnelle d’expertise comptable, droit, conseil et audit présente sur la Savoie (73), la Haute-Savoie (74), l’Isère (38) et les Hautes Alpes (05). Nous proposons à nos 12 000 clients professionnels un accompagnement en matière comptable, juridique, sociale, fiscale et...
-
Sr Manager, Clients Nationaux Hors Foyer
Il y a 3 mois
Issy-les-Moulineaux, France Coca-Cola Europacific Partners Temps pleinVous recherchez de nouveaux challenges professionnels au sein de CCEP ? Nous avons une opportunité pour vous ! En charge d’un portefeuille de clients nationaux sur un ou plusieurs segments (QSR, Restauration à Table, Loisirs, Transports, etc ). En ligne avec la stratégie et les priorités de Coca-Cola European Partners vous définissez, négociez et...
