Associate Clinical Site Manager

Summary

Independently monitors the progress of assigned Investigative sites by maintaining close contact with site personnel and Site Monitors.Coordinates and maintains effective communication (oral, written), and serves as a BMS contact for the Investigator.Provides feedback and status updates to internal stakeholders.Independently manages activities at the site by providing guidance as required and by collaborating with other key stakeholders.Documents substantive contacts concisely and in accordance with SOPs.Identifies potential site issue and suggests resolutions.Demonstrates understanding of data management activities and performs clinical data review to monitor data quality and coordinate resolution of clinical discrepancies.Skilled in the use of technology.Demonstrates a thorough understanding of all steps in the clinical research process.

Requirements

Bachelor's degree in Life Sciences, Allied Health, Nursing or Pharmacy, and 3-5 years of clinically related or relevant experience.Thorough understanding of ICH/GCP guidelines and regulations as they relate to protocol/site management.Knowledge of general clinical research including Investigator site issues, important milestones and strategies to ensure timelines are met.Knowledge of the pharmaceutical industry and the pre-clinical, clinical, regulatory and commercial components.A detailed understanding of project planning and management methods.Knowledge of Data Management Systems.