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Who are they?
Chez Johnson & Johnson, ils pensent qu’une bonne santé est la base de vies plus dynamiques, de communautés prospères et de progrès. C’est pourquoi, depuis plus de 130 ans, leur objectif est de contribuer à aider les personnes à rester en bonne santé à tous les âges et à toutes les étapes de la vie.
Grace a une large gamme de produits au travers de trois entités – Janssen, Johnson & Johnson Santé Beauté France (JJSBF), Johnson & Johnson MedTech – Le groupe Johnson & Johnson s’engage à soutenir les personnes tout au long de leur vie et à adopter une approche globale des soins à travers la prévention, le diagnostic et la thérapie. Ils investissent dans la recherche et le développement pour améliorer la santé et le bien-être des personnes. Ils créent un environnement où la diversité des points de vue et les dialogues ouverts sont encouragés, permettant ainsi aux collaborateurs de se développer. En favorisant la collaboration entre les secteurs, entre les fonctions et avec des partenaires stratégiques, ils agissent comme une seule et même entreprise envers les communautés et le monde extérieur.
Ils comptent sur vous, sur vos idées et sur votre enthousiasme pour les aider à accomplir leur mission : implémenter de nouvelles idées afin d’améliorer la qualité de vie pour tous.
Chez Johnson & Johnson, travail et bien-être sont liés. Ambition et simplicité vont de pair.
Johnson & 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 the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today's world.We are currently recruiting for our pharmaceutical division (Janssen) a Clinical Research Associate ED&CP (M/F) to be based in Issy-les-Moulineaux (France) on a permanent contract.A Site Manager (Clinical Research Associate) in Early Development & Clinical Pharmacology (ED&CP) serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of complex early development and/or clinical pharmacology studies.A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Healthcare compliance (HCC) requirements, applicable regulations and guidelines from start-up through data-base lock.Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA, Trial Manager (TM) and Global Trial leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols.Principal Responsibilities:
- Acts as primary local company contact for assigned sites for specific trials.
- May participate in site feasibility and/or pre-trial site assessment visits
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
- Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
- Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
- Arranges for the appropriate destruction of clinical supplies.
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Ensures accuracy, validity and completeness of data collected at trial sites
- 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. For AEs/SAEs, ensures 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 relevant systems utilized for trial management.
- Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- A minimum of 2 year of clinical trial monitoring experience is preferred.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
- Proficient in speaking and writing the country language and English. Good written and oral communication.