Clinical Trial Manager

Location: Root D4, CH, 6039Novocure 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, novel, antimitotic treatment modality 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 or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.

For our team in Root, Switzerland we are looking for a

**Clinical Trial Manager**

As Clinical Trial Manager, you will independently implement and oversee all areas of clinical trial management including, but is not limited to, managing day-to-day activities from start-up to closeout on (multiple) clinical trials and management of vendors such as Contract Research Organizations (CROs) and/or investigative sites.

**Your responsibilities**:

- Implement and successfully conduct clinical trials per Novocure’s internal Standard Operating Procedures, Good Clinical Practice regulations as well as applicable country’s regulations
- Prepare the writing of clinical documents and the study execution plans
- Ensure activities comply with the applicable Novocure Quality System requirements
- Managing the completion of routine and advanced trial start-up, conduct, and close-out activities to industry and corporate standards
- Lead TMF review and tracking of CRO
- Track key trial activities and milestones
- Initiate and coordinate feasibility assessment, potential investigator identification, and site selection
- Oversight of study-specific tools (including communication tools such as newsletters, flyers, etc.)
- Responsible for oversight of vendor performance, internal metrics, and communication of trial status within and outside the trial team
- Plan, implement and track clinical budgets
- Review and approve Vendor invoices, including investigator grants and pass-through costs
- Organize and participate in investigational meetings and site training representing assigned clinical trial
- Lead the follow-up of in-house and on-site sponsored quality audits, co-monitoring visits with CRO monitors, as well as, regulatory authority inspections
- Train and mentor clinical operations team members such as Jr. CTMs and CTAs

**Your profile**:

- Minimum of 6 years' experience working in different positions in the field of clinical trials; CRA-level experience is a plus
- Minimum of 2 years of experience in leading clinical trials (phases II-III)
- Knowledge of regulatory affairs
- Familiarity with Medical Device regulations, clinical trials, and ISO
- Experience leading Clinical Trial Processes
- Experience in global management is a plus
- Oncology experience preferred
- Experience in the management of CROs and other service providers (including central laboratories)
- Working knowledge of ICH/GCP
- Fluency in English
- Average travel commitment of 25-30%, which includes overnight and international travel as needed