The Clinical Lead/associate Clinical Lead provides direction and guidance to the project team, coordinate site management and monitoring activities, and communicating status of these activities to the PM.
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:
- Minimum of 5 years as a CRA (and at least 12 months tenure at NVT for internal applicants)
- 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
- Proven leadership experience, including successfully leading and developing teams, preferably across multiple countries and regions, with the ability to foster collaboration and drive high performance in a global environment.
- Demonstrated track record of delivering complex project outcomes, consistently achieving key milestones, meeting deliverables, managing risks, and ensuring projects are delivered on time, within scope, and to a high standard of quality.
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 contacting you regarding your application
About UsNovotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.
Novotech Sydney, New South Wales, AUS Office
Sydney, Australia
