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Senior Site Manager (H/F)

Johnson & Johnson

Issy-les-Moulineaux, FranceSeniorH-1B sponsor company
Sign in to applyVerified 1h ago
Location
Issy-les-Moulineaux, France
Work model
On-Site
Level
Senior
H-1B history
2 approvals (FY2023)
Posted
12h ago

Skills

GCP

About this role

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: Issy-les-Moulineaux, France Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a driven Senior Site Manager, located in Paris region Ile-de France (France) to serve as the primary contact point between the Sponsor and the Investigational Site for trials in phases 2 to 4, located France (Hybrid). Purpose: The position is within the Oncology-hematology therapeutic area and will include monitoring 2-3 trials . As Senior Site Manager, you will be responsible for maintaining ongoing inspection readiness and compliance with the clinical trial protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations from study start-up through to site closure. Our new colleague should be flexible and is able to work independently. We are seeking to hire a strong communicator, a quick learner, a problem solver, and a real team player. You will be responsible for oversight of clinical trial protocols at a site level and will collaborate closely with a Local Trial Manager (country project manager), Clinical Trial Assistant, Clinical Trial Manager (regional project manager) and Trial Delivery Leader. You will be part of a hardworking, enthusiastic, and committed study team eager to deliver and help improve the lives of millions of patients. You will also be part of a wider local French team that provides mutual support and opportunities to work together to identify new and improved ways of working. You will be responsible for: Activities ranging from site feasibility and selection over site initiation and start-up, to preparation and conduct of site monitoring, oversight of key performance indicators and site/study close-out in complex clinical trials. The implementation of a site-level analytical risk-based monitoring model and for working with the site to ensure timely resolution of issues and deviations identified during monitoring visits. Ensuring the accuracy and completeness of all trial data including safety data. Managing timely data entry and query resolution in collaboration with site staff. Co-creating site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas. Ensuring full documentation of trial related activities in all study files; communicates site and study progress and issues to the Local Trials manager and central study teams. Being the local expert in assigned protocols and build the necessary therapeutic area knowledge. Coaching or mentoring less experienced colleagues. You may participate to process improvement and training. Leads

Senior Site Manager (H/F) at Johnson & Johnson, Issy-les-Moulineaux, France | Yoinka