Local Trial Manager
Johnson & Johnson
Warsaw, Poland
7 d. temu

AtJanssen, 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.

Global Clinical Operations (GCO) Poland is the part of Janssen organization specialized in conducting clinical trials to evaluate the efficacy and safety of new therapeutic solutions.

GCO Poland is looking for candidates on the position of :

Contract : Permanent

Senior Local Trial Manager (Senior LTM) is accountable for successful execution of clinical trials at the country level with adherence to timelines, budget, compliance with all GCO SOPs, policies and regulatory requirements.

Main Activities :

  • Providing operational oversight of the trial including planning, execution and monitoring through all its phases
  • Providing coordination and leadership of local study team to deliver results as per country commitment
  • Monitoring study progress and initiating corrective / preventive actions, if needed
  • Reviewing Monitoring Visits Reports and managing issues accordingly
  • Performing site feasibility
  • Shaping long-term professional relationships with sites and investigators
  • Mentoring Site Managers
  • Qualifications :

  • At least 4 years of experience in monitoring of clinical trials or at least 1-year experience in project management acquired in pharma company or CRO
  • Sound understanding of drug development process including ICH / GCP and local regulatory requirements
  • Ability to make decisions under time pressure and prioritize accordingly
  • Ability to identify risks and implement corrective / preventive actions
  • Ability to negotiate over conflicting issues and develop win-win outcomes
  • Excellent communication, networking, coordination and influencing skills
  • Proficiency in speaking and writing English
  • We Offer :

  • Interesting job in a prestigious international healthcare company
  • Highly professional environment
  • Friendly and supportive team members and management
  • Opportunities for professional growth and career development
  • Possibilities to take part in different projects
  • Motivating financial remuneration
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