Johnson & Johnson Karriere

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

Nordrhein-Westfalen, Deutschland
Clinical Trial Administration


Arbeitsplatzbeschreibung

Requisition ID: 1805624549W

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.

 

The Early Development & Clinical Pharmacology (ED&CP) Trial Manager (TM) is responsible for the local management of a trial and to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements.

 
We’re looking for a
 

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

 

Main Focus will be in acting as the primary point of contact at a country level for assigned studies from start-up to database lock and closeout activities. 

 
Responsibilities:
 
  • Is responsible for study feasibility and site/lab assessments, providing recommendation of suitable sites for selection to participate in the trial. Ensures appropriate follow-up of pre-trial visit report.
  • Collaborates with the CPL (Clinical Program Lead), GTM (Global Trial Manager), functional management and Protocol Owner to select final site list.
  • Contributes input to the development of e.g. the Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for trials to which no GTM is assigned.
  • Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) 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 (if applicable).
  • Contributing to process improvement initiatives; training and mentoring of Site Managers and Clinical Trial Assistants
  • Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and SharePoint sites) by using study tools and management reports available to analyze trial progress.
  • Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans.
  • May submit requests for vendor services and may support vendor selection. Reviews and approves site and local vendor invoices as required
  • May lead negotiation of trial site contracts and budgets. May be responsible for forecasts and management of GCO budget to ensure accurate finance reporting and trial delivered within budget. Adheres to finance reporting deliverables and timelines.
  • 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.
  • Works with SM to ensure CAPAs are developed and implemented for audits and inspection or any quality related visits
  • Acts as expert for assigned protocols. Develops therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.

Qualifikationen
  • 4-year University degree in Life Sciences, Nursing, or related scientific field is required.
  • Minimum of 4 years of pharmaceutical and/or clinical trial experience and project management is mandatory.
  • Profound understanding of the drug development process including ICH/GCP and local regulatory requirements. 
  • Fluent language skills in German and English (oral and written).
  • Excellent communication and negotiation skills, combined with hands-on mentality working style.
  • Profound expertise in IT systems (CTMS, eCRF and MS Office)
  • Flexible mindset and ability to work at a fast pace within small exploratory study teams.
  • Ability to work on multiple trials in parallel in different disease areas.
 

This is an office-based position in Neuss. Nevertheless, travel ability is necessary (co-monitoring, site initiations).


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
1805624549W