Associate Director, Clinical Operations User Management

    • Titusville, NJ

Janssen Pharmaceutical Companies part of the Johnson & Johnson Family of Companies is recruiting for an Associate Director, Clinical Operations User Management. This position can be located in Raritan, NJ., Titusville, NJ., Chesterbrook, PA., or Beerse, Belgium. Remote locations within the United States and Europe may be considered.

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 Associate Director, Clinical Operations User Management to be accountable for the oversight and management of user access and security, for systems and processes dedicated to supporting our internal and external clinical trial community.

With $81.6 billion in 2018 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

This position provides expertise in Clinical Operations User Management in order to guarantee support required by the Enabling Business Information Solutions (EBIS) organization. The Associate Director is a member of the Shared Solutions group, working with EBIS and other groups across Global Development, supporting solutions, projects and tasks related to user management and security.

Role and responsibility:

  • Accountable for strategy development and execution on how to streamline and simplify access management to clinical trial systems
  • Responsible for defining a streamlined security model (and operational processes and tool) to manage automated workflow for provisioning and deactivation of users across the full landscape of clinical systems for all users. User types for the systems in scope are J&J employees, contractors/flex/consultants, CRO users, Site users/HCPs, and also Patients.
  • Simplify and implement a clear and concise user access review process and ensure compliance/security/privacy
  • Continue to enhance and drive initiatives within the user management space to meet business needs (MaSCoT, SHARP)
  • Active participant and extended team member of Single Sign-On (SSO) Initiative, which is to provide Investigators/site staff a single username and password for access to key clinical trial systems with a central access point (portal). Oversight of any implemented SSO solution.
  • Strong customer service and partnering, to work closely with business representatives and technology partners to drive toward common goals and business needs, while also influencing a broad range of multi-disciplinary teams
  • Knowledge and experience within the validation, compliance, data security and data privacy areas, to ensure that all provided solutions are staying in compliance with internal and external regulations.
  • Technical background, in order to lead with focus on developing integrated, automated and maintainable technical solution with a focus on efficiency
  • Analyses and provides solutions to the Head of Shared Solutions to assist in the decision-making process.
  • Requires relevant system and technical knowledge as well as related industry guidance and best practices.
  • Provides guidance and is a resource to Global Development for Clinical Operations-supported systems.
  • Remains current on specific expertise.
  • Works on complex projects. Ensures quality project deliverables as agreed upon with internal and external customers.
  • Shares expertise across Global Development to assure consistency and accuracy within process and functionality.
  • Identifies and participates in process, system, and tool improvement initiatives within EBIS
  • Participates in non-trial/non program projects to gather information or provide knowledge in expertise area.
  • Coordinates across all the EBIS systems owners and corresponding vendors (most of our systems are SaaS)
  • Need to be innovative and forward-thinking when developing security management approaches
  • Vendor and contract management negotiation and oversight, including oversight of any solutions or 3rd parties handling operational aspects of user management
  • Supports audit and inspections as appropriate.
  • Strong sense of customer service and partnering, to work closely with business representatives and technology partners to drive toward common goals and business needs, while also influencing a broad range of multi-disciplinary teams
  • Strong validation and compliance experience, to ensure that all provided solutions are staying in compliance with internal and external regulations.
  • Strong technical background, in order to lead with focus on developing integrated, automated and maintainable technical solution with a focus on efficiency.
  • This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Qualifications

  • BS/BA in Computer Sciences required, MBA preferred.
  • Pharmaceutical industry experience highly preferred.
  • 10 or more years of experience in technology service management required.
  • 5 or more years of experience in team management for service/system management required
  • 5 or more years of experience in system validation and required.
  • 10 or more years of experience in program management and project management required.
  • Strong experience in optimization projects preferred.
  • Strong experience in business relationship management in the context of R&D (Discovery and Clinical Development) required.
  • Working experience in vendor specific solutions preferred.
  • Outstanding written and verbal communication skills in English required.
  • Experience in prioritizing and managing multiple tasks simultaneously
  • Experience with working with others to achieve results.
  • Teamwork experience, especially working in global, virtual teams
  • Experience leading projects and teams
  • Certification in project management/continuous improvement (Project Management (PM), Flawless Project Execution (FPX), GreenBelt) a plus
  • Internal & External partnering (conflict management, negotiations)
  • Experience in providing Subject Matter Expertise to stakeholders across all levels, geographic regions and organizations
  • Strong business partnering and influencing skills to drive results
  • Strong presentation skills with ability to communicate and engage at all levels within the organization, demonstrated leadership and influencing skills in a complex, multi-cultural, matrix environment.
  • Self-motivated problem solver who thrives in a dynamic and customer-focused environment
  • Strong strategy management, analytical thinking, problem solving, learning agility, communication and collaboration skills are required.
  • Ability to travel up to 10% of the time.


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.

Primary Location
United States-New Jersey-Titusville-
Other Locations
North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Chesterbrook, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
0231200304


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