Start-Up Lead
Blue Bell, Pa
- Implements the project start-up methodology, to include project parameters, subject recruitment months, & high-level study start-up activities/statuses, & documents the information within the Project Start-Up Plan, CTMS, and the Project Start-Up Summary- Creates, maintains, & facilitates Sponsor Approval of project documents related to study start-up, including Essential Document Templates, Essential Document Review Requirements, Country & Site Standard Investigational Product Release Forms- Prepares & presents a project-specific overview to Clinical Operations, Investigator Grant Management, & Global Regulatory Affairs staff regarding start-up deliverables, timelines, & processes- Oversees site identification & recruitment activities for all allocated countries, including liaising with other departments when additional site are needed, & escalates delays, where applicable- Oversees Local Regulatory Affairs Lead, Contracts Associate, & In-House Clinical Research Associate(s) to ensure that essential documents for allocated regions are developed, collected, reviewed, & tracked according to the processes and timelines agreed upon on the project- Collaborates with Global Regulatory Affairs Lead assigned to the project to ensure Ministry of Health, Central Independent Ethics Committee, & other central submissions are performed in line with site activation timelines- Serves as primary liaison & primary point of escalation for project start-up issues for assigned countries- Conducts meetings to ensure all relevant team members are properly trained on start-up activities & kept current on timelines, clinical activities, & contract and budget status- Uses available tools to establish site activation forecasts & ensures critical path activities are on target- Facilitates the transition of study activities and status to the Clinical Trial Manager & Clinical Research Associate(s) as sites/countries move out of start-up and into conduct