JOB PURPOSE: Support Line manager/Submission team leader for implementing regulatory strategy to obtain the regulatory approval Responsible for part of the regulatory submission of new product Responsible for regulatory submission for group marketed products ORGANIZATIONAL CONTEXT:
Job Overview: Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Summary of Responsibilities: Responsible for all
Job Overview: The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation
Job Overview: Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Summary of Responsibilities: Responsible for all
Job Overview Assist with coordination and prioritization of department workload liaising with Project Management and Investigator Services groups (comes out). Ensure accuracy of shipments of laboratory test kits and ancillary supplies. Provide leadership to team in
Job Description Summarized Purpose: Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs. Conducts site visits to assess protocol and
