Global Trial Leader - Medical Affairs Operations (1 of 1)
- United States
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. and Canada
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.
Reporting to the MAO Global Program Leader (GPL) the GTL MAO is accountable for end-to-end operational management of data generation activities according to timeline and budget for assigned projects. This includes start-up, execution, close-out, analysis and reporting with high quality standards per company procedures and regulatory requirements.
The GTL MAO serves as the single point of end-to-end accountability for assigned programs leading the teams on a global, regional level and/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.
• Single point of accountability for end-to-end operational management of the assigned projects
Accountable for delivery of assigned programs within agreed budget. Ensures accurate project budget management, reconciliation and forecasting for both Out of Pocket (OOP) costs and FTE costs. Responsible for overall oversight and contract management, including review & approval of external service provider (ESP) contracts, and change orders.
•Tracks project progress against planned timelines. Ensures timely and accurate documentation and communication of project progress.
• Maintains project compliance within all applicable Health Authority (HA) regulations, guidelines, SOPs and processes. Ensures quality oversight and inspection readiness of assigned projects. Participates in preparation for, and conduct of, HA inspections and audits.
• Ensures correct and timely reporting of safety and product complaints, as appropriate.
• Identifies, proactively manages and escalates issues in a timely manner.
• Manages risks and creation of proposal for Action Plan(s) with the project team to implement solutions on a project level.
- Bachelor's degree or equivalent required, preferably in Life Sciences with a minimum of 8 years of clinical research experience in the pharmaceutical industry or CRO required.
- Strong working knowledge of ICH-GCP, standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures required.
- Strong IT skills in appropriate software required.
- Excellent decision-making and strong financial management skills is required.
- Project management skills and excellent communication skills required.
- Ability to work in a virtual and highly matrixed environment.
- Leadership skills and ability to influence without authority is required.
- Willingness to travel with occasional overnight stay(s) according to business needs.
- Experience in Oncology, Immunology, Cardiovascular, Neuroscience and/or Infectious Diseases and Vaccines preferred
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-
Canada, United States
Janssen Research & Development, LLC (6084)
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