Johnson & Johnson Careers
Please enter a valid email.
Unfortunately, our network is not responding. Please try again later.
Your job alert was successfully created.
Senior Specialist Central Monitoring Manager
Requisition ID: 1805632839W
‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
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.
Tasks & responsibilities:
- 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.
- Providing input into lessons learned activities related to ARBM.
Based Monitoring studies.
- Contributes to the ongoing development of the ARBM model of clinical trial management and related processes.
Required Minimum Education: Bachelor’s Degree
Required Years of Related Experience: A minimum of 3 or more years of relevant work; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Required Knowledge, Skills and Abilities:
Clinical trials experience (i.e. clinical operations, data management, biostatistics, or other relevant clinical development experience) in the pharmaceutical/medical device industry or CRO.
Knowledge of ICH-GCP and overall drug development processes.
Ability to operate and proactively use various systems and databases (CTMS, Rave, QRM Dashboard, Spotfire, etc.) to analyze trial quality/performance and compliance and identify trends and early warning signals.
Data analysis and technical skills in the area of clinical trials/clinical data.
Strong ability to effectively communicate and understand issue escalation.
Advanced skills allowing smooth and effective communication, including the ability to manage multiple communication streams.
Ability to work with a set of predefined risks and adapt to new protocol-specific risks.
Ability to successfully lead cross-functional study teams.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Janssen-Cilag Netherlands (8345)
Clinical Trial Administration