J&J Family of Companies Associate Director, Central Monitoring (1 of 2) in Netherlands

Janssen Research & Development, LLC, a member of the J&J Family of Companies is recruiting for an Associate Director, 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 Associate Director, Risk Management - Central Monitoring, plans, validates and manages the central monitoring process in conformance to all relevant laws, regulations, guidelines, policies and procedures and will take the lead on continuous improvement of internal processes. At this level, the position has a greater degree of impact on the business results and is responsible for managing a group of other Risk Management - Central Monitoring staff.

Principal responsibilities will include:

  • Responsible for designing, planning and executing the central monitoring aspect of clinical trials being conducted under analytical risk based monitoring (ARBM).

  • Lead the development and implementation and continuous improvement of the Analytical Risk Based Monitoring (ARBM) activities and generating detailed central monitoring group processes.

  • Provide guidance and training to the group of central monitors for the activities they are responsible for (the range of tasks will include activities such as providing input into the integrated ARBM plan, monitoring guidelines and source data verification plan, ensuring historical site performance is gathered, performing trend analysis, maintaining oversight on site risk parameters and ensure appropriate actions are taken by the trial coordination and site management organization, monitor operational risk parameters at a trial level, spot checks of monitoring visit reports, lead lessons learned activities related to central monitoring.

  • Manages the day-to-day activities of the central monitoring of clinical trials in accordance with the standard operating procedures and good clinical practices

  • Accountable for managing the day-to-day activities of the central monitoring staff in accordance with the standard operating procedures and good clinical practices

  • Creates and maintains liaisons with Global Clinical Operation, Portfolio Delivery Organization and Data Delivery and Analysis groups and with external contract research organizations to ensure high quality of data in clinical studies through adequate management of risk signals and implementation of mitigation plans.

  • Oversees the staff performing central monitoring of studies through interpretation of risk indicators and other trends, documents implications and provides status reports and identifies actions, follow up on completion of actions.

  • Assists in the preparation of yearly budget and financial targets related to central monitoring aspect. Ensures the control of expenditures and monitoring of budgetary targets

  • Performs hiring, training, talent management and performance development activities ion of staff on regular basis

  • Drive the central clinical trial monitoring activities across the various phases of the trial execution as outlined in the end to end process.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Qualifications

  • A minimum of a BS degree is required

  • Master’s Degree is preferred.

  • A minimum of 8 or more years of relevant work is required.

  • Clinical trials experience required (i.e. clinical operations, data management, biostatistics, or other relevant clinical development experience) in the pharmaceutical industry or CRO. Team lead experience or functional management experience is required.

  • Knowledge of ICH-GCP and overall drug development processes is required.

  • Deep understanding of the Janssen R&D clinical operations model including the roles and responsibilities of the different stakeholders preferred.

  • Good understanding of clinical research operations including on-site monitoring and site management is required.

  • 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.

  • 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.

Primary Location

United States--

Other Locations

Europe/Middle East/Africa-Netherlands, North America-United States, Asia Pacific

Organization

Janssen Research & Development, LLC. (6084)

Job Function

Clinical Trial Coordination

Requisition ID

00001AN2