Docs Global (Continental Europe)

Trial Manager MAO *** France*** Home based / office based

Location
France
Salary
Competitive
Posted
02 Mar 2021
Closes
31 Mar 2021
Ref
27070
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Description:

• Maintains liaisons with clinical research organizations or internal clinical trials administration and operations department to initiate and expedite clinical studies on products that have investigational new drug or medical device approvals

• Monitors reporting systems to look for trends and/or issues in the data/study conduct metrics.
• Analyzes/summarizes the data for reporting
• Supports compliance with global health authority regulations and guidelines an internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the SMT operate in a constant state of inspection readiness.
• Work With Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools

• Support staff, as appropriate, in the set-up and coordination of Investigator Meetings, if applicable. Presentation of training materials at internal/external training opportunities

• Supports team by monitoring budgets and expenditures as required by trial budget and expectations.

• Support availability of required reports to manage/ensure real time tracking of trial status according to Trial Plan

Profile:

• University/Bachelors Degree or Equivalent
• Minimum of 3 years clinical trial execution experience in the pharmaceutical industry
• Requires clinical research operational knowledge, project planning/management and communication skills.
• Good working knowledge of ICH, GCP and FDA guidelines/regulations
• Solid understanding for the drug development process with a special emphasis on clinical development
• Ability to multi-task
• Excellent computer skills

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