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Manager, Risk Management and Central Monitoring


Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies is recruiting for a Manager, Risk Management and Central Monitoring to be based at any Janssen R&D site in North America, Asia, or Europe.

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.

The Manager, Risk Management and Central Monitoring will be accountable for the oversight, execution, and management of the Analytical Risk-Based Monitoring (ARBM) processes and day-to-day activities for one or more programs and/or assigned trials in conformance to all relevant laws, regulations, guidelines, policies and procedures.

Principal Duties and Responsibilities:
  • Oversee a group of professionals consisting of the Central Monitoring Managers (CMMs) in a matrix structure.
  • Share responsibility for the quality of the data on compound, study, country and site levels with the assigned CMMs and with all applicable functions.
  • Represent the Risk Management-Central Monitoring Group on program team meetings.
  • Handle assignments that are more complex and/or have a greater potential impact on business results.
  • May lead initiatives related to continuous improvement of internal processes and also contribute to the mentoring/training of other CMMs in the Risk Management-Central Monitoring Group.
  • Oversee, execute and/or manage the RM-CM group activities across the various phases of ARBM trial design and execution as outlined in the end to end process, including tasks associated with start-up, execution and close out, and in all phases of trial monitoring for designated trials.
  • Serve as the Risk Management-Central Monitoring representative for assigned programs/studies by establishing and maintaining liaisons with Program Teams, internal cross-functional colleagues, and/or with external contract research organizations.
  • Perform training, development, evaluation of staff performance and assists in hiring.
  • Proactively assist the development and implementation and continuous improvement of the ARBM activities and generating detailed central monitoring group processes.
  • A minimum of a Bachelor’s degree or equivalent University degree is required. Master’s degree preferred.

Qualifications
  • A minimum of 6 years of relevant work experience is required.
  • Must be fluent (both oral and written) in English.
  • Clinical trials experience (i.e. clinical operations, data management, statistics, or other relevant clinical development experience) in the Pharmaceutical industry or Clinical Research Organization (CRO) is required.
  • Team lead or functional management experience is required.
  • Knowledge of ICH-GCP and overall drug development processes required.
  • Deep understanding of the Janssen R&D clinical operations model, including the roles and responsibilities of the different stakeholders preferred.
  • The ability to operate and proactively use various systems and databases (CTMS, Rave, QRM Dashboard, Spotfire, etc.) to analyze trial quality/performance and compliance and pick up trends and early warning signals is required.
  • The ability to identify risk and trends required.
  • Data analysis and technical skills in the area of clinical trials/clinical data is required.
  • Strong ability to effectively communicate and understand issue escalation is required.
  • Advanced communication skills allowing smooth and effective communication lines required.
  • Ability to manage multiple communication streams is required.
  • Ability to work with a set of predefined common risk, and ability to adapt/be flexible to adapt to protocol-specific risks is required.
  • Good understanding of clinical research operations, including on-site monitoring and site management is preferred.
  • Ability to effectively lead cross-functional teams in a matrix environment is required.
  • Ability to identify and lead process improvement opportunities is required.
  • This position requires up to 10% travel both domestic and international.

Johnson -n- Johnson is an equal opportunity employer


Primary Location
United States-New Jersey-Raritan
Other Locations
North America, Asia Pacific, Europe/Middle East/Africa
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Trial Administration
Requisition ID
00001AD5