Senior Clinical Support Specialist
Spring House, PA, USA | Johnson & Johnson
Functions:IT / Information Technology
Job Description:85 people have viewed this job
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Clinical Support Specialist located in Spring House, PA.
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.
• The Senior Clinical Support Specialist will review and provide comments on the specifications documents (protocols, statement of works and lab manuals) from internal groups, Central Laboratories, and outsourced bioanalytical laboratories for studies where the department will be conducting analyses, receiving results, or has oversight of an external laboratory.
• This individual will ensure feasibility of proposed sample and data management and to provide comments based on best practices, GCP/GLP considerations, and overall study efficiency.
• Manage sample specifications database for the studies.
• Participate or lead teams to execute process improvements.
• Review of Central Laboratories investigator site training slide decks and site letters.
• Work cross-functionally with business partners to align and standardize best practices.
• Work cross-functionally to align GLP/GCP practices with other Janssen business partners.
• Maintain the highest level of GLP/GCP practices.
Education and Experience Requirements:
• A minimum of BS in biology, chemistry, computer science or related discipline or equivalent required OR a Master’s degree or other advanced degree with a minimum of 3 years relevant pharmaceutical/scientific experience; OR a bachelor’s degree with a minimum of 5 years of relevant pharmaceutical/scientific experience.
• Ability to work in a cross-functional global team environment is required.
• Basic understanding and experience reviewing lab based technical documents (e.g., Protocols, Statement of Works, and/or Lab Manuals) is required.
• Good organization, attention to detail and time management skills required.
• Builds solid and positive relationships with cross-functional team members is required.
• Strong expertise in areas of GLP/GCP is required.
• Must have strong global and written communication skills and the ability to communicate effectively across all levels of the organization is preferred.
• Identifies problems and process improvement opportunities and drives resolution is preferred.
• Strong leadership skills (influencing, negotiating, assertiveness, taking initiative) is 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.
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