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About the Role
The Clinical Lead/Associate Clinical Lead provides direction and guidance to the project team, coordinates site management and monitoring activities, and communicates the status of these activities to the PM.
Responsibilities
- 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.
- 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 correspond directly with the sponsor to provide information/updates.
Requirements
- 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.
- 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.
- 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.
- 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.
Skills
- Leadership
- Organization skills
- Communication skills
- Meeting deadlines
- Coaching
- Mentoring
- Verbal and written English fluency
- Team leadership
- Team development
- Collaboration
- High performance
- Project outcome delivery
- Risk management
- Quality assurance
- Strategic mindset
- Proactive decision making
- Partnership
- Collaboration
Experience Level
- Senior level
- Minimum of 5 years as a CRA
Benefits
- Flexible working options
- Paid parental leave for both parents
- Flexible leave entitlements
- Wellness programs
- Ongoing development programs
- NovoLife, our flexible benefits framework
About the Company
- Novotech 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.
Equal Opportunity
- 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.
- 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.