Johnson & Johnson Karriere

Site Manager (m/f) Early Development & Clinical Pharmacology

Nordrhein-Westfalen, Deutschland
Clinical Trial Administration


Arbeitsplatzbeschreibung

Requisition ID: 1805624544W

Within Janssen Research & Development, our Global Clinical Operations (GCO) team is responsible for all trial coordination, site management and monitoring activities across Early Development, Late Development and Medical Affairs trials across five therapeutic areas. Through more than 1.500 associates across the world, we drive the operational planning and execution of over 350 clinical trials in 40 countries. As Global Clinical Operations, we are the face of Janssen to our investigators and our patients.

 
We are currently looking for a
 

Site Manager (m/f) Early Development & Clinical Pharmacology

 
Main Tasks:
 
  • Conduct of site/lab assessments, pre-trial site assessment visits and/or study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team
  • Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM (Trial Manager) and TA (Therapeutic Area) team regarding study progress and issue resolution.
  • Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
  • Ensures site staff have current GCP and necessary protocol and compound training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed internally.
  • Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
  • Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented and destroyed.
  • Ensures site staff complete the data entry and resolve queries within expected timelines.
  • Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
  • Fully documents trial related activities with respect to study monitoring, e.g writing of visit reports and completion of follow-up letters to investigators. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
  • Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.


Qualifikationen
  • 4-year University degree in Life Sciences, Nursing, or related scientific field
  • A minimum of 2 years of clinical trial monitoring experience is preferred, particular in monitoring ED&CP studies is preferred
  • Strong knowledge of ICH-GCP, company standard operating procedures, 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 regular and also on short-time notice with overnight stay away from home depending on the region & location of sites
  • Proficient in speaking and writing German and English
  • Flexible mindset and ability to work at a fast pace within small exploratory study teams with accelerated cycle times
  • Ability to work on multiple trials in parallel in different disease areas

This is a Home office based position.


The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.



Primärer Standort
Deutschland-Nordrhein-Westfalen-
Organisation
Janssen-Cilag Germany (8000)
Funktion
Clinical Trial Administration
Requisition ID
1805624544W