JUNIOR CLINICAL SITE MONITOR WITH RISK BASED MONITORING LAWRENCEVILLE, NJ The role is required to be in the office 50% over 2 weeks. Hybrid.
The Contract Central Monitor will perform Central Monitoring activities.
The Central Monitor (CMN) plays a critical role contributing to the development, embedding, growth and health of the central monitoring capability in support of Risk Based Monitoring (RBM) methodology adopted by the client.
The CMN is responsible for the remote assessment of Risk Indicators that identify issues and emerging risks in study-specific variables (trends / outliers / poor performing sites) through the review of aggregate data.
Central monitors are responsible for the review of clinical and operational data.
The CMN will interact with clinical teams and regionally based Site Monitors/Managers to support the oversight of the sites/studies as per the Risk Based Monitoring methodology adopted by the client.
Support and contribute to the development, embedding, growth and health of the necessary business process to support risk mitigation and global monitoring processes that align with the risks of client's programs and protocols.
Support execution of RBM processes as a part of cross-functional teams spanning the R&D portfolio (all therapeutic areas and phases of development).
Utilize analytics/visualizations to review aggregate data for the remote assessment of Risk Indicators that identify issues and emerging risks at the study, program, country, therapeutic and functional level, to ensure risks are addressed consistently.
Identify critical data issues and document findings for tracking and timely resolution.
Contribute to the development of or provide feedback on documented processes developed for risk-based monitoring methodology being adopted by the client.
Contribute to the development of or provide feedback on training material developed to support RBM methods.
Accountable for supporting global inspection readiness and inspections in regard to RBM monitoring process and tactics.
Provide user input on IT needs necessary to support all aspects of RBM.
Contribute to the development and maintenance of metrics that inform the evaluation of central monitoring performance and effectiveness.
Acts as a change agent with stakeholders across R&D, including educating, bridging knowledge across functions, and developing effective partnerships with critical stakeholders.
4 Year Degree required in one of the following disciplines or related field: Life Sciences, Analytics, Data Science, Statistics, Business.
Demonstrated ability to effectively communicate ideas/concepts and to motivate others to accomplish challenging shared goals and objectives.
Well-versed in analytical and conceptual capabilities .
Demonstrated ability to apply critical thinking and identify, distinguish relative importance and be able to work through issues remotely.
Demonstrated knowledge of clinical operations, inclusive of site monitoring, management, and data management .
Demonstrated knowledge of Good Clinical Practices (GCP) .
Demonstrated ability to absorb critical knowledge on relevant protocol/trial design
requirements as well as relevant clinical/disease area knowledge .
Demonstrated ability to successfully manage competing priorities to achieve the goals of the department and the larger organization.
Thorough knowledge of global regulatory and guideline (inclusive of ICH GCP) requirements with clinical experiences in a drug development capacity.
Demonstrated ability to build and maintain strong relationships across organizational and/or geographic boundaries through participation on cross-functional teams.
3+ Years in drug development is preferred .
3+ Years in the field of site management, site monitoring, data management or related is preferred .
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-03320
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE