Senior Global Trial Lead / Senior Clinical Trial Manager
In this pivotal role, you will oversee the global conduct and delivery of a large Phase III international clinical trial in NSCLC (non-small cell lung cancer) within the Thoracic program.
About Novocure
We are a global oncology company developing a non-invasive, antimitotic therapeutic alternative called Tumor Treating Field (TTF), for patients with solid tumors. Our proprietary technology aims to slow or reverse tumor progression by inducing tumor cell death.
Your Key Responsibilities:
* Independently implement and oversee all areas of clinical trial management.
* Ensure oversight of investigative site feasibility, selection and start-up, clinical monitoring and site management, regulatory submissions, and trial budget.
* Serve as the primary Sponsor contact for all project stakeholders both internally and externally, including for CROs/vendors.
* Manage CROs/vendors when services are outsourced.
* Review and approve Vendor invoices, including investigator grants and pass-through costs.
* Lead and manage global Phase III trials.
* Plan, implement, and track clinical budgets.
* Organize and participate in investigational meetings and site training representing assigned clinical trial.
* Accountable for project financial management, and change control, budget reconciliations and forecasting.
* Oversee and contribute to the development and implementation of cross-functional clinical trial documents.
* Oversee and/or assist with IRB/IEC and regulatory submissions and meetings as required; liaise with global team to ensure alignment with study objectives and milestones.
* Drive positive, solution-oriented communication and ensure accountability across all levels.
* Perform risk management, including identifying, tracking, and evaluating potential risks and mitigation strategies; maintain risk log and implement risk responses.
* Support the coordination of study-specific quality audits and regulatory authority inspections, acting as a Subject Matter Expert (SME).
* Manage Clinical Operations team members to appropriate and timely completion of projects.
* Train and mentor other Clinical Operations personnel, providing leadership oversight and motivation.
* Lead initiatives to accelerate program delivery and support the approval of new devices in their indicated uses.
* Prepare study reports as required.
Your Qualifications:
* Bachelor's degree from an accredited college or university, or equivalent work experience, preferably in Life Sciences.
* 8+ years' experience in cross-functional trial management in a pharmaceutical, biotechnology or CRO.
* Excellent knowledge of large international Phase III trials conduct.
* High expertise in study start-up activities and deliverables.
* Strong understanding in oncology, especially lung cancer, and solid tumors in general.
* Proven expertise in CRO and vendors management, budget control, and contract oversight.
* High sense of adaptability to new processes and growing environments.
Your Skills:
* Positive, proactive, and solution-oriented mindset.
* A high degree of self-organization and time management.
* Ability to lead with a forward-thinking collaborative attitude and one team spirit.
* A strong sense of accountability and delivering within established timelines and required quality.
* Excellent stakeholder management and communication skills.