Clinical Lead

About the Role

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

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

Experience and Qualifications

·    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

Salary Band - $135,000 – $160,000 Salary offered will be based on candidates experience level.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.  

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.
 

Novotech is a global full-service clinical Contract Research Organization (CRO).

Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.