Standard operating procedures (sops) and work instructions (wi)
Responsible for the quality deliverables at the country level; follows project requirements and aapplicable country rules with moderate oversight from the SSU Country Manager
Job Summary
Responsible for the quality deliverables at the country level; follows project requirements and aapplicable country rules with moderate oversight from the SSU Country Manager.
Oversee site activation end to end process at country/ site level.
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
Matching Summary
Responsible for the quality deliverables at the country level; follows project requirements and aapplicable country rules with moderate oversight from the SSU Country Manager.
Skills & Requirements
Must-have
country level quality deliverables
forecasted submission/approval timelines
Standard Operating Procedures (SOPs) and Work Instructions (WI)
essential document collection
Central EC Applications, Local EC Applications, RA Applications
local country regulatory intelligence
Nice-to-have
passionate problem solvers
agile and driven
authentically be yourself
diversity of thoughts, backgrounds, cultures, and perspectives
Key Requirements
Bachelor’s Degree
understanding of clinical trial process across Phases II-IV and ICH GCP
Ability to understand clinical protocols
Detailed understanding of clinical trial start-up processes