\\n 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, 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 clinical team in Root, Switzerland we are looking for a
Junior Clinical Trial Manager
As (Jr.) Clinical Trial Manager you will implement and oversee all areas of clinical trial management, including, but not limited to, managing day-to-day activities, trial start-up, conduct, and closeout activities on (multiple) clinical trials and management of vendors such as management of Contract Research Organizations (CROs) and/or investigative sites.
Your responsibilities:
Ensure that clinical trials are conducted per the protocol, country regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures
Participate in the writing of clinical documents and the study execution plans
Ensure activities comply with the applicable Novocure Quality System requirements
Lead TMF review and tracking of CRO
Ensure the progress and completion of the trial(s) in-line with trial goals
Participate in feasibility assessment, potential investigator identification, and site selection
Preparation of study-specific tools (including communication tools such as newsletters, flyers, etc.)
Participate in preparing trial-specific updates for management and cross-functional areas
Participate in the planning, implementation, and tracking of clinical budgets
Review vendor invoices and approve investigator grants and pass-through costs
Organize and participate in investigational meetings and site training representing assigned clinical trial
Participate in the preparation and 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 CTAs and Sr. CTAs
Your profile:
Bachelor\\\'s degree preferably in Nursing, Medicine or other Life Sciences, or RN degree from an accredited school or equivalent
Minimum of 4-year experience working in different positions in the field of clinical trials, including CRA-level experience (both CRO and industry experience are acceptable)
You are familiar with regulatory affairs, Medical Device regulations, clinical trials and ISO
Experience leading Clinical Trial Processes
Experience in review and tracking of regulatory documentation for successful implementation of clinical trials
Experience as CRA (working for CRO or sponsor company) would be an advantage
Working knowledge of ICH/GCP
We are looking forward to receive your application to Natalia Kochanowicz, Talent Partner EMEA through our Career portal. Please find more information about Novocure and our therapy on our website.\\n \\n \\n \\n \\n \\n