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Senior Specialist, Central Monitoring Manager - 2406178691W
Description
Central Monitoring Manager
Location.: Preferably from Warsaw and surroundings
Full time job
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 responsibilities & the impact YOU will have:
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, ARBM-related input into the monitoring guidelines and the creation of tSDV specifications with a high degree of influence on translating ARBM concepts.
Analyzes data from available reporting mechanisms and dashboards and concisely organizes potential risks for reporting out at the Central Monitoring Working Group (CMWG). Identifies CtQ items that require the development of study specific reports and in turn works with statisticians & programmers to translate those CtQs into easily interpretable reports.
Exhibit high degree of leadership skills to support ARBM strategies and leads the cross-functional CMWG.
Analyzes and identifies risks 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.
Provides input into lessons learned activities related to ARBM.
Contributes to the ongoing development of the ARBM model of clinical trial management and related processes
Perform other work-related duties as assigned.
Qualifications
We would love to hear from YOU, if you have:
Minimum: B.S. degree required. Preferred: Master’s Degree in Life Sciences.
Three or more years of relevant work. Clinical trials experience in the pharmaceutical/medical device industry or CRO. However, other relevant experiences and skills may be considered.
Knowledge of basic statistical concepts and data science principles.
Understanding of the Janssen R&D clinical operations model.
Understanding of clinical research operations including on-site monitoring and site management.
Knowledge of ICH-GCP, risk identification, management and analysis and overall drug development processes.
Data analysis and technical skills in the area of clinical trials/clinical data
Strong ability to effectively communicate and understand issue escalation
Advanced leadership skills allowing smooth and effective communication, including the ability to manage multiple communication streams and exert influence on ARBM concepts with key stakeholders within the cross-functional study team
This is what awaits YOU at J&J:
An opportunity to be part of a global market leader.
A dynamic and inspiring working environment.
Many opportunities to work on challenging projects and assignments.
Possibilities for further personal as well as professional development.
Many employee benefits.
Employee benefits are regulated by an internal policy that contains full details regarding the entitlement and conditions for the benefits.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
That is why we in Johnson & Johnson are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
Primary Location Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw
Organization Janssen-Cilag Polska Sp. z o.o. (7824)
Job Function Clinical Data Management
Req ID: 2406178691W