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R&D Operations

Site Manager

  • ชื่อเรื่อง Site Manager
  • การทำงาน R&D Operations
  • ฟังก์ชั่นย่อย Clinical Trial Support
  • ประเภท Analyst, Clinical Trial Support (P4 - E24)
  • ตำแหน่งที่ตั้ง Budapest, Hungary
  • โพสต์
  • ID การร้องขอ 2406173356W
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At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson.  Please visit www.janssen.com for more information.

Johnson and Johnson is recruiting for a  Site Manager  located in Budapest, Hungary.

Contract: Full time

We are looking for a driven Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for assigned clinical trials (phase 1-4) in Hungary. As Site Manager, you have to ensure 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 collaborate with a Local Trial Manager (LTM), a Clinical Trial Assistant (CTA), and a Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols. You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.

Key Responsibilities:

  • 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.
  • Responsible for 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.
  • Ensure accuracy and completeness of all trial data including safety data. Manage timely data entry and query resolution in collaboration with site staff.
  • Co-create site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas.
  • Ensures full documentation of trial related activities in all study files; communicates site and study progress and issues to the Local Trial Managers and central study teams.
  • Be the local expert in clinical trials and build the vital therapeutic area knowledge.
  • May participate to process improvement and training. Leads and/or participates in special initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or ''Subject Matter Expert'.

คุณสมบัติ

Education:

  • BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)

Experience and Skills:

Required:

  • A minimum of 1,5-2 years of clinical trial monitoring experience is preferred, including on-site monitoring; however, other relevant working experiences and skills may be considered by the hiring manager
  • Strong proven understanding of GCP, local laws, and regulations
  • Strong IT skills in appropriate software and company systems
  • Willingness to travel with occasional overnight stay away from home
  • Proficient in Hungarian and English. Good written and oral communication skills

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our enthusiastic organization. We are Janssen!

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.

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