Johnson & Johnson Careers

Clinical Operations Specialist

Spring House, Pennsylvania
R&D


Job Description

Requisition ID: 1134180125

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
This Clinical Operations Specialist is responsible for assisting with the oversight and implementation of biomarker strategic objectives as directed by the Translational Research Leads in clinical trials including, sample quality, timeliness, biomarker administrative needs (budget, presentations and study documents), continuous process improvement, and change management. This role is responsible for all biomarker sample logistics within clinical trials from study start up through final close out visit ensuring that all regulatory and organizational requirements are met.
Key Responsibilities:
• Assist Translational Research (TR) Lead in the oversight, management and implementation of the TR clinical plan
• Collaborate with GCDO and other functions to support sample/result management
• Assist BM lead with preparation of study related documents, tracks samples and assist team with queries, site training, and sample destruction
• Contributes to key elements of strategic development for a program

Other Responsibilities:
• Function independently and communicate clearly within an environment that relies heavily on effective communication and collaborating in a matrix.
• Able to solve problems within own area of expertise.
• Provides perspective and provide sample logistic information.
• Provide input to the broad protocol design and review cycle.
• Represent Translational Research community in cross-functional meetings and teams on an ad hoc basis
• Actively seek input, listen, and understand operational and scientific strategies.
• Share accurate information with peers, supervisor, or work team.
• Prepare reports and deliver clear and effective presentations.
• Proactively seek new learning opportunities. Identify sources of knowledge independently to enhance personal growth. Share experience with others willingly

Qualifications
• Must have Bachelor’s Degree or higher degree, with 4 plus years of industry-related experience.
• Related Clinical Research certifications preferred (GCP)
• Good knowledge and understanding of clinical research, ICH, GCP, GLP, data management, and regulatory and legal issues related to samples.
• Good understanding of shipping and clinical regulations.
• Basic understanding of human physiology, pharmacology and genetics


Primary Location
United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
1134180125