Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate oversight from the SSU Country Manager.
Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.
Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Responsible for one or more of the following functions at the country level:
Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager.
Country Start-Up Advisor
QUALIFICATION & REQUIREMENTS (please indicate if 'preferred')
Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
Ability to understand clinical protocols and associated study specifications.
Detailed understanding of clinical trial start-up processes.
Ability to manage external vendors to contract effectively.
Strong organizational skills with ability to handle multiple tasks effectively.
Strong written and verbal communication and interpersonal skills.
Ability to manage multiple project budgets with increased complexity and value.
Quality-driven in all managed activities.
Good negotiating skills.
Good problem-solving skills.
Demonstrated ability to work independently as well as part of a team.
This Job Excludes CO Applicants
INC Research Inc