Senior Clinical Trial Manager
vor 6 Stunden
As a Senior Global Trial Lead / Senior 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 global end-to-end activities of the clinical trial worldwide with a focus on start-up activities, CRO/Vendors oversight and management of internal and external cross function stakeholders. Your 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 global oncology company with a Patient forward vision developing a non-invasive, antimitotic, novel therapeutic alternative called Tumor Treating Field (TTF), for patients with solid tumors. TTF utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure has ongoing and 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:
- 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.
- 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.
- 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.
- 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).
- Manages Clinical Operations team members to appropriate and timely completion of projects.
- 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.
- Prepare study reports as required.
Your experience/acknowledgment:
- Bachelor’s degree from an accredited college or university, or equivalent work experience, preferably in Life Sciences required.
- 8+ 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.
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