Country Study Startup Specialist – Part Time

Role Overview

• 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
• 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
• 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
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
• Follows the project direction provided by the designated country start-up advisor (CSA) and SAM
• May serve as a point of contact for the PM/SAM (or designee) during start-up on allocated projects
• Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site
• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required
• 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
• May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues
• Oversee site activation end to end process at country/ site level

Requirements

• Bachelor’s Degree
• 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

Tech Stack

• Google Cloud Platform

Benefits

• 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
• We are committed to building an inclusive culture – where you can authentically be yourself