CTL

About the position

The Clinical Lead provides direction and guidance to the project team, coordinating site management and monitoring activities, and communicating status of these activities to the Project Manager.

Responsibilities

Regional Clinical Lead responsibilities may include, but are not limited to;

Start-up

· Support and coordinate feasibility, site identification, and site selection activities for multi-regional studies

· Lead and assist with preparation of initial ethics and regulatory submission package and oversight on approval processes and timelines

· Support PM with application and tracking Investigational Product (IP) and ancillaries import/export permits and licenses

· Work with PM to coordinate initial IP shipment across regions

Ongoing/monitoring phase

· Lead internal CRA meetings/teleconferences and may be required to prepare for the meeting, presenting a section of the agenda and follow-up with specific tasks. May assist with preparing the agenda, meeting minutes and distributing additional communication

· May attend Sponsor meetings and contribute as required. May assist with preparing the agenda, meeting minutes and distributing additional communication

· May correspond directly with the sponsor to provide information/updates

Minimum Qualifications & Experience:

· Must have performed advanced clinical monitoring tasks and site management tasks across multiple locations at a senior level and demonstrated effective leadership, organization skills, communication skills, and the ability to meet deadlines in a fast and dynamic environment.

· Experienced in coaching and mentoring clinical teams.

· Good communication skills and fluency in both verbal and written English