Clinical Trial Manager

at  Novocure

Location:Root D4, CH, 6039
About the Job
As a Clinical Trial Manager within Novocure Global Clinical Operations based in our headquarters offices in Switzerland, you will ensure the conduct and delivery of large Phase III international Clinical Trial in NSCLC (non-small cell lung cancer) within the Thoracic program. You will oversee the end-to-end activities of the clinical study into a given region(s) and countries with a focus on start-up activities, CRO/Vendors oversight and management of internal and external cross function stakeholders.
Your CTM role is crucial in driving success, bringing significant value to the business, and enjoying a role that empowers you to thrive in your expertise. It is also about joining a talented, passionate, and engaged humble team in a collaborative environment where cutting-edge science meets a positive, forward-thinking mindset.
About Novocure
A Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, antimitotic, novel therapeutic alternative, antimitotic treatment modalityalternative for patients with solid tumors, called Tumor Treating Field (TTF) for patients with solid tumors. TTF which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing andor completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer and other types of solid cancers.

Your responsibilities include:

• Ensure oversight of investigative site feasibility, selection and start-up, clinical monitoring and site management, regulatory submissions, and trial budget.
• Serves as the primary Sponsor contact for all project stakeholders both internally and externally, including for CROs/vendors.
• Manages CROs/vendors, when services are outsourced.
• Lead and manage international Phase III trials within a given region(s) and countries.
• May be assigned as a Global Trial Lead, overseeing regional CTMs on global trials.
• Accountable for project financial management, and change control, budget reconciliations and forecasting
• Oversees and contribute to the development and implementation of cross-functional clinical trial documents
• Oversees and/or assists with IRB/IEC and regulatory submissions and meetings as required; liaises with global team to ensure alignment with study objectives and milestones
• Drive positive, solution-oriented communication and ensure accountability across all levels.
• Performs risk management, including identifying, tracking, and evaluating potential risks and mitigation strategies; maintains risk log and implements risk responses
• Supports the coordination of study-specific quality audits and regulatory authority inspections, acting as a Subject Matter Expert (SME)
• Trains and mentors’ 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.

Your experience/acknowledgment:

• Bachelor’s degree from an accredited college or university, or equivalent work experience, preferably in Life Sciences required
• 5+ years’ experience in cross-functional trial management in a pharmaceutical, biotechnology or CRO
• Excellent acknowledgment 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-up environment.

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

Please note that while our HQ is currently in Root, we will be relocating to Baar by the beginning of 2025.
We are looking forward to receive your application through our ApplicantPortal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.

• Ensure oversight of investigative site feasibility, selection and start-up, clinical monitoring and site management, regulatory submissions, and trial budget.
• Serves as the primary Sponsor contact for all project stakeholders both internally and externally, including for CROs/vendors.
• Manages CROs/vendors, when services are outsourced.
• Lead and manage international Phase III trials within a given region(s) and countries.
• May be assigned as a Global Trial Lead, overseeing regional CTMs on global trials.
• Accountable for project financial management, and change control, budget reconciliations and forecasting
• Oversees and contribute to the development and implementation of cross-functional clinical trial documents
• Oversees and/or assists with IRB/IEC and regulatory submissions and meetings as required; liaises with global team to ensure alignment with study objectives and milestones
• Drive positive, solution-oriented communication and ensure accountability across all levels.
• Performs risk management, including identifying, tracking, and evaluating potential risks and mitigation strategies; maintains risk log and implements risk responses
• Supports the coordination of study-specific quality audits and regulatory authority inspections, acting as a Subject Matter Expert (SME)
• Trains and mentors’ 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