The position of Study Start up Lead provides leadership to Study Start-up employees at the project level and is accountable for achieving site activation in terms of quality, time and budget. The position covers activities at the project level with direct oversight on business contributors working in simple project team structures.
Your responsibilities will be the following:
* Develop and deliver project level study start-up training, start-up plan, and coordinate deliverables from all stakeholders who participate in start-up activities.
* Review and approve study start-up documents which include sending for final approval for drug release.
* Manage the maintenance of CTA, EC and central IRB submissions throughout the study and oversee the site contracting function via Site Contract Lead/Associates.
* Support development of and present study materials at investigator/study launch meetings when required.
* Ensure efficient distribution of workload and site assignments within the team.
* Participate in business development proposals, defense meetings and proposal development.
* Ensure quality of the start-up deliverables within a project and maintain proper visibility of its progress by the use of tracking tools.
* Ensure efficient dissemination of information across the Study Start-up team within the project.
* Interact with clients and other functional departments related to start-up activities and deliverables.
* Ensure alignment of activities to budget.
* Support the identification of study start-up out of scope activities, including supporting the completion of the start-up aspects of change orders.
* Act as project manager on regional studies with limited scope of work (study start-up).
* Oversee CTA activities where they are related to start-up deliverables.