- Data Management
- Research and Development
Senior Specialist, Risk Management and Central Monitoring (1 of 3)
Location: North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC., a member of the J&J Family of Companies is recruiting for a Senior Specialist, Risk management and Central Monitoring to be based at any Janssen R&D site in North America, Asia, or Europe.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
- The Senior Specialist executes and manages the Analytical Risk-Based Monitoring (ARBM) processes and day-to-day activities for up to five trials of medium complexity and three trials of high complexity or a combination of high and medium complexity trials in conformance to all relevant laws, regulations, guidelines, policies and procedures.
- The focus of this position is to take primary responsibility for the ARBM-related study set-up processes and to manage the execution of central monitoring activities assigned to the CMM(s) during trial execution, as outlined in the end to end process, including maintaining oversight of site/regional/study risk parameters.
- The Senior Specialist leads the preparation, conduct, and follow-up of the cross-functional Central Monitoring Working Group (CMWG) for Analytical Risk Based Monitoring studies and shares the responsibility for the quality of the data with all applicable functions.
- The Senior Specialist CMM may be given assignments that are more complex and/or have a greater potential impact on business results. The Senior Specialist may represent the Risk Management-Central Monitoring Group on program team meetings.
- The Senior Specialist will lead the cross-functional study team in the completion of ARBM-related study start-up processes, such as the protocol assessment, protocol de-risking, iARBM plan creation, establishment of initial site risk levels, and the creation of tSDV specifications. The Senior Specialist will also provide ARBM-related input into the Monitoring Guidelines.
- Identifies and oversees potential issues and findings requiring further review and follow-up as part of routine CMM work and CMWG conduct and ensures appropriate actions are taken by the central/local teams members (e.g. GCO, Portfolio Delivery, IDAR) to investigate, resolve and document potential risks identified via CMM data review, including ensuring adequate documentation of resolution.
- Lead of the cross-functional Central Monitoring Working Group (CMWG) for Analytical Risk Based Monitoring studies.
- Providing input into lessons learned activities related to ARBM.
- Contributes to the ongoing development of the ARBM model of clinical trial management and related processes
- Describe important tasks or duties, not mentioned above, that is performed infrequently and are not critical to accomplishing the essential functions of the job
- Bachelor’s degree or equivalent University degree is required
- Master’s Degree is preferred
- A minimum of 3 or more years of relevant work is required.
- Clinical trials experience required (i.e. clinical operations, data management, statistics, or other relevant clinical development experience) in the pharmaceutical/ Medical Device industry or CRO is required.
- Team lead experience or functional management experience is required.
- Knowledge of ICH-GCP and overall drug development processes 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.
- 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.
- This position requires up to 10% travel both domestic and international.