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Clinical Site Monitor
Ref No.: 17-01655
Location: Lawrenceville, New Jersey
Position Type:Contract
Start Date: 12/06/2017
CLINICAL SITE MONITOR
LAWRENCEVILLE, NJ


Project Description:
  • The Senior Central Monitor (Sr. CMN) is responsible for the remote assessment of Risk Indicators that identify issues and emerging risks in clinical trial study-specific variables (trends / outliers / poor performing sites) through the review of aggregate data.
  • Sr. CMN is responsible for the review of clinical and operational data.
  • Sr. CMN will interact with HQ clinical teams and regionally based Site Monitors/Managers to support the oversight of the sites/studies as per the Risk Based Monitoring (RBM) methodology being adopted by Client.

Required Skills:
  • Demonstrated ability to support execution of RBM processes as a part of cross-functional teams spanning the R&D portfolio (all TAs & phases of dev).
  • Use analytics/visualizations to review aggregate data for the remote assessment of Risk Indicators that identify issues & emerging risks at the study, program, country, TA and functional level, to ensure risks are addressed consistently.
  • Identify critical data issues & document findings for tracking and timely resolution.
  • Demonstrated ability to effectively communicate ideas/concepts to accomplish challenging shared goals and objectives.
  • Contribute to the development of and provide feedback on documented processes developed for RBM methodology being adopted by Client.
  • Provide user input on IT needs necessary to support all aspects of Risk Based Monitoring
  • Demonstrated knowledge of clinical operations, inclusive of site monitoring/site management and data management.
  • Use of software independently and without assistance: Basic office tools (e.g. MS Suite); software and tools used for Central Monitoring activities (e.g. SAS, J-review, Spotfire).
  • Ability to contribute to the development of and provide feedback on training material developed to support RBM methodology.
  • Accountable for ensuring global inspection readiness in regards to RBM monitoring process and tactics.
  • Ability to contribute to the development and maintenance of metrics that inform the evaluation of central monitoring performance and effectiveness.
  • Degree preferred in one of the following disciplines or related fields: Life Sciences, Analytics, Data Science, Statistics, Informatics, Business, Finance.
  • 5+ years in drug development and 3+ years in the field of data management, programming, statistics, finance or related.
  • Primary location in Princeton.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

ALPHA'S REQUIREMENT #17-01655
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE