J&J Family of Companies Global Trial Leader MAO in Titusville, New Jersey
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Global Trial Leader – Medical Affairs Operations, located in Titusville, NJ or remotely within the U.S.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Global Trial Leader serves as the single point of end-to-end accountability for assigned programs leading the program teams on a global, regional level or local level, while partnering with the Global Program Leader (GPL), Global Operations Head (GOH), Global Trial Leader-Clinical Trial Assistant (GTM-CTA) to ensure overall program delivery at the global, regional and country level. As well as be accountable for end-to-end operational management of data generation activities or managed access requests. This includes start-up, execution, close-out, analysis and reporting according to planned timelines and budget, and with high quality standards per company procedures and regulatory requirements.
As a Global Trial Leader, you will:
• Single point of accountability for end-to-end operational management of the assigned programs
• Is accountable for delivery of assigned programs within agreed budget, including forecasting and pro-active management of program specific budgets
• Tracks project progress against planned timelines.
• Maintains project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs and processes.
• Ensures correct and timely reporting AEs/SAEs/PQCs, as appropriate
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for program management.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
• Identifies and proactively manages issues in a timely manner
• Bachelor’s degree or equivalent required, preferably in Life Sciences.
• Minimum of 8 years of clinical research experience in the pharmaceutical industry or CRO.
• Specific therapeutic area experience may be required depending on the position.
• Project management skills in a clinical trial setting.
• Ability to work in a virtual and highly matrixed environment.
• Strong working knowledge of ICH-GCP, of local laws and regulations required.
• Strong IT skills in appropriate software and company systems.
• Excellent decision-making and strong financial management skills.
• Leadership skills and ability to influence without authority.
• Be an agent of change management.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Titusville-
Janssen Research & Development, LLC (6084)
J&J Family of Companies
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