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
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